K960615 is an FDA 510(k) clearance for the GAUZE COMPRESS. This device is classified as a Gauze/sponge, Internal.
Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on November 25, 1996, 286 days after receiving the submission on February 13, 1996.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K960615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 13, 1996 |
| Decision Date | November 25, 1996 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |