Data / Medical devices / United States / Chemence Medical Inc.
Chemence Medical Inc.: FDA-registered device maker in Alpharetta, GA, United States, 9 510(k) clearances
Chemence Medical Inc. is registered with the FDA (registration 3010034760) in Alpharetta, GA, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 9, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010034760
- Address
- 200 Technology Dr, Alpharetta, GA, United States, 30005
- Owner or operator
- CHEMENCE MEDICAL INC. (9054055)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- July 30, 2004
- Registered through
- 2026
- Brand names listed
- Exofin Fusion Skin Closure System, Exofin Mastic, Exofin Micro, GluGone, Leukosan Ultra-High Viscosity Cyanoacrylate, Liquid Skin, Premier Pro Exofin Precision Pen, Premier Pro exofin High Viscosity Tissue and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Contract manufacturer | accessdata.fda.gov |
| Cutaneous Tissue Adhesive With Mesh | OMD | 2 | Manufacturer | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | KGG | 3 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2021 | K212246 | Exofin Precision Pen | MPN | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| December 17, 2020 | K200264 | Exofin High Viscosity Topical Skin Adhesive | MPN | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| June 5, 2020 | K191461 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| September 25, 2017 | K171442 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| December 22, 2016 | K162352 | derma+flex QS High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| February 9, 2016 | K152476 | Exofin High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| July 28, 2010 | K101276 | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| June 19, 2006 | K053409 | 3M LIQUID BANDAGE | KMF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| February 23, 2006 | K050757 | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE | KMF | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cutaneous Tissue Adhesive With Mesh
- All makers of Solvent, Adhesive Tape
- All makers of Bandage, Liquid
- All makers of Tissue Adhesive For The Topical Approximation Of Skin
- All makers of Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- All makers of Tape And Bandage, Adhesive
Updated September 9, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.