The following data is part of a premarket notification filed by Surgimetrics International, Ltd. with the FDA for Suture Non-absorbable Silk.
| Device ID | K931913 |
| 510k Number | K931913 |
| Device Name: | SUTURE NON-ABSORBABLE SILK |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | SURGIMETRICS INTERNATIONAL, LTD. 4233 THAMESGATE CLOSE Norcross, GA 30092 |
| Contact | Ron Laporte |
| Correspondent | Ron Laporte SURGIMETRICS INTERNATIONAL, LTD. 4233 THAMESGATE CLOSE Norcross, GA 30092 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-16 |
| Decision Date | 1994-03-03 |