The following data is part of a premarket notification filed by Surgical Specialties, Inc. with the FDA for Suture Nonabsorbable - Silk.
| Device ID | K930826 |
| 510k Number | K930826 |
| Device Name: | SUTURE NONABSORBABLE - SILK |
| 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 |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620708992032 | K930826 | 000 |
| 00304040000595 | K930826 | 000 |
| 00304040000588 | K930826 | 000 |
| 00304040000571 | K930826 | 000 |
| 00304040000564 | K930826 | 000 |