The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Dexon 's' Polyglycolic Acid Mesh.
| Device ID | K830889 |
| 510k Number | K830889 |
| Device Name: | DEXON 'S' POLYGLYCOLIC ACID MESH |
| Classification | Mesh, Surgical |
| Applicant | DAVIS & GECK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-05-09 |