K945656 is an FDA 510(k) clearance for the THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Micro-Medical Devices, Inc. (Castle Pines Village, US). The FDA issued a Cleared decision on March 28, 1995, 131 days after receiving the submission on November 17, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K945656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1994 |
| Decision Date | March 28, 1995 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |