The following data is part of a premarket notification filed by Glycar, Inc. with the FDA for Glycartissue Repair Patch Family Of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible.
| Device ID | K963368 |
| 510k Number | K963368 |
| Device Name: | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | GLYCAR, INC. 3003 LBJ FREEWAY SUITE 100 Dallas, TX 75234 |
| Contact | Bertram Hudson |
| Correspondent | Bertram Hudson GLYCAR, INC. 3003 LBJ FREEWAY SUITE 100 Dallas, TX 75234 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1997-10-31 |
| Summary: | summary |