K955322 is an FDA 510(k) clearance for the PROTEC X-RAY DETECTABLE GAUZE SPONGE, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Derivados DE Gasa, S.A. DE C.V. (Palm Harobor, US). The FDA issued a Cleared decision on December 19, 1995, 29 days after receiving the submission on November 20, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K955322 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 1995 |
| Decision Date | December 19, 1995 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4450 |