The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Surgical Suture, Nonabsorable Stainless Steel.
Device ID | K930740 |
510k Number | K930740 |
Device Name: | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL |
Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
Contact | Harry C Savard |
Correspondent | Harry C Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
Product Code | GAQ |
CFR Regulation Number | 878.4495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-12 |
Decision Date | 1994-07-26 |