K955678 is an FDA 510(k) clearance for the RNS STERILE DISPOSABLE PUNCTURE TRAY. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on February 21, 1996, 69 days after receiving the submission on December 14, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K955678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1995 |
| Decision Date | February 21, 1996 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |