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 |