Data / Medical devices / United States / FR Tech, LLC
FR Tech, LLC: FDA-registered device maker in Springboro, OH, United States, 2 510(k) clearances
FR Tech, LLC is registered with the FDA (registration 3042750477) in Springboro, OH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 26, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042750477
- Address
- 195 Advanced Dr, Springboro, OH, United States, 45066
- Owner or operator
- FR Tech, LLC (10094689)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- CURCO 1" x 1" Collagen Sheet, CURCO 1" x 10" Collagen Sheet, CURCO 1" x 4" Collagen Sheet, CURCO 2" x 10" Collagen Sheet, CURCO 2" x 2" Collagen Sheet, CURCO 4" x 4" Collagen Sheet, CURCO 7" x 7" Collagen Sheet, CURCO Collagen Particles 1g and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 26, 2012 | K122325 | SKINTEMP II | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
| April 2, 1991 | K910944 | MEDIFIL | KGN | Substantially Equivalent | Biocore | accessdata.fda.gov |
Compare with other makers
Updated October 26, 2012. 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.