K953830 is an FDA 510(k) clearance for the KENSORB, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Kentron Health Care, Inc. (Hollywood, US). The FDA issued a Cleared decision on October 3, 1995, 48 days after receiving the submission on August 16, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K953830 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1995 |
| Decision Date | October 03, 1995 |
| Days to Decision | 48 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 |