K955723 is an FDA 510(k) clearance for the STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS). This device is classified as a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II - Special Controls, product code GAQ).
Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on February 27, 1996, 71 days after receiving the submission on December 18, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4495.
| 510(k) Number | K955723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 18, 1995 |
| Decision Date | February 27, 1996 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4495 |