The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Stainless Steel Sutures, Flexon Steel Sutures (stainless).
Device ID | K955723 |
510k Number | K955723 |
Device Name: | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) |
Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant | DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
Contact | Stephen J Tamsett |
Correspondent | Stephen J Tamsett DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
Product Code | GAQ |
CFR Regulation Number | 878.4495 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-18 |
Decision Date | 1996-02-27 |