K941455 is an FDA 510(k) clearance for the STERILE GAUZE PRODUCT LINE. This device is classified as a Gauze/sponge, Internal.
Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on May 20, 1994, 56 days after receiving the submission on March 25, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K941455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 25, 1994 |
| Decision Date | May 20, 1994 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |