The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethi-pack* Surgical Stainless Steel Suture.
| Device ID | K931271 |
| 510k Number | K931271 |
| Device Name: | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John D Paulson |
| Correspondent | John D Paulson ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GAQ |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAT |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1994-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031036809 | K931271 | 000 |
| 20705031036717 | K931271 | 000 |
| 20705031036724 | K931271 | 000 |
| 20705031036731 | K931271 | 000 |
| 20705031036748 | K931271 | 000 |
| 20705031036755 | K931271 | 000 |
| 20705031036762 | K931271 | 000 |
| 20705031036779 | K931271 | 000 |
| 20705031036786 | K931271 | 000 |
| 20705031036793 | K931271 | 000 |
| 20705031036700 | K931271 | 000 |