The following data is part of a premarket notification filed by Surgimetrics International, Ltd. with the FDA for Stainless Steel Suture.
| Device ID | K931915 |
| 510k Number | K931915 |
| Device Name: | STAINLESS STEEL SUTURE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| 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 | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-16 |
| Decision Date | 1994-03-03 |