K983348 is an FDA 510(k) clearance for the DYNAREX TRACHEOSTOMY SPONGE, a Gauze/sponge, Internal, submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on December 11, 1998, 79 days after receiving the submission on September 23, 1998. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K983348 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1998 |
| Decision Date | December 11, 1998 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |