The following data is part of a premarket notification filed by Glycar, Inc. with the FDA for Glycar Tissue Repair Patch.
| Device ID | K942911 |
| 510k Number | K942911 |
| Device Name: | GLYCAR TISSUE REPAIR PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Contact | Dirk A Frater, M.d. |
| Correspondent | Dirk A Frater, M.d. GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-12-14 |