K953057 is an FDA 510(k) clearance for the CYLINDRICAL SPONGE. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY).
Submitted by Medical Perspectives Corp. (Norwalk, US). The FDA issued a Cleared decision on September 14, 1995, 76 days after receiving the submission on June 30, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K953057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 1995 |
| Decision Date | September 14, 1995 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4450 |