K955683 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on February 1, 1996, 49 days after receiving the submission on December 14, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K955683 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 1995 |
| Decision Date | February 01, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MJG — Device, Percutaneous, Biopsy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |