The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stainless Steel, Gut, Poly (glycolide/l-lactide) Polyamide, Polypropylene, Poly (ethylene Terephthalate) And Silk.
| Device ID | K946173 | 
| 510k Number | K946173 | 
| Device Name: | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | 
| 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 | GAL | 
| Subsequent Product Code | GAM | 
| Subsequent Product Code | GAP | 
| Subsequent Product Code | GAR | 
| Subsequent Product Code | GAT | 
| Subsequent Product Code | GAW | 
| CFR Regulation Number | 878.4495 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1994-12-19 | 
| Decision Date | 1995-01-09 |