Data / Medical devices / United States / Combe Laboratories, Inc.
Combe Laboratories, Inc.: FDA-registered device maker in Rantoul, IL, United States, 1 510(k) clearance
Combe Laboratories, Inc. is registered with the FDA (registration 1450238) in Rantoul, IL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 1, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450238
- Address
- 200 Shelhouse DR., Rantoul, IL, United States, 61866
- Owner or operator
- COMBE INCORPORATED (2412672)
- Roles
- Manufacturer
- First device listed
- October 20, 1992
- Registered through
- 2026
- Brand names listed
- SEA BOND DENTURE ADHESIVE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | KXX | 1 | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | 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 |
|---|---|---|---|---|---|---|
| May 1, 2015 | K150615 | Vaginal Moisturizing Gel | NUC | Substantially Equivalent | Combe Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Updated May 1, 2015. 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.