The following data is part of a premarket notification filed by Surgical Specialties, Inc. with the FDA for Suture Absorbable- Gut.
| Device ID | K932037 |
| 510k Number | K932037 |
| Device Name: | SUTURE ABSORBABLE- GUT |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| 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 | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1994-01-07 |