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 |