K983016 is an FDA 510(k) clearance for the GAUZE, SPONGES, CAT # 11-003, a Gauze/sponge, Internal, submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on February 12, 1999, 168 days after receiving the submission on August 28, 1998. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K983016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 28, 1998 |
| Decision Date | February 12, 1999 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |