The following data is part of a premarket notification filed by Glycar, Inc. with the FDA for Glycar Tissue Repair Patch, Bio-patch, Uro-sling.
| Device ID | K963175 |
| 510k Number | K963175 |
| Device Name: | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING |
| Classification | Mesh, Surgical |
| Applicant | GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Contact | Dirk Frater |
| Correspondent | Dirk Frater GLYCAR, INC. 4537 BELCLAIRE AVE. Dallas, TX 75205 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-09-23 |
| Summary: | summary |