K944879 is an FDA 510(k) clearance for the GAUZE SPONGES, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 23, 1994, 81 days after receiving the submission on October 3, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K944879 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1994 |
| Decision Date | December 23, 1994 |
| Days to Decision | 81 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 |