The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Zimmer Collagen Repair Patch.
| Device ID | K053562 |
| 510k Number | K053562 |
| Device Name: | ZIMMER COLLAGEN REPAIR PATCH |
| Classification | Mesh, Surgical |
| Applicant | TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington, GA 30014 |
| Contact | Angela Bunn |
| Correspondent | Angela Bunn TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington, GA 30014 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-21 |
| Decision Date | 2006-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884523000573 | K053562 | 000 |
| 10884523000566 | K053562 | 000 |
| 10884523000269 | K053562 | 000 |