The following data is part of a premarket notification filed by Surgimetrics International, Ltd. with the FDA for Suture Non-absorbable Synthetic Polylmide.
| Device ID | K931914 |
| 510k Number | K931914 |
| Device Name: | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | SURGIMETRICS INTERNATIONAL, LTD. 6525 CORNERS PKWY. SUITE 400 Norcross, GA 30092 |
| Contact | Ron Laporte |
| Correspondent | Ron Laporte SURGIMETRICS INTERNATIONAL, LTD. 6525 CORNERS PKWY. SUITE 400 Norcross, GA 30092 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-16 |
| Decision Date | 1994-10-05 |