The following data is part of a premarket notification filed by Surgical Specialties, Inc. with the FDA for Suture Nonabsorbable-nylon,silk,polyester,stainles.
| Device ID | K930825 |
| 510k Number | K930825 |
| Device Name: | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading, PA 19607 |
| Contact | Linda Texter |
| Correspondent | Linda Texter SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading, PA 19607 |
| Product Code | GAP |
| Subsequent Product Code | GAL |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1994-01-07 |