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 |