K945021 is an FDA 510(k) clearance for the FLUFF GAUZE SPONGE. This device is classified as a Gauze/sponge, Internal.
Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 23, 1994, 72 days after receiving the submission on October 12, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K945021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1994 |
| Decision Date | December 23, 1994 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |