K922961 is an FDA 510(k) clearance for the VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS,. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Cameo, Inc. (Toledo, US). The FDA issued a Cleared decision on March 23, 1993, 278 days after receiving the submission on June 18, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K922961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | June 18, 1992 |
| Decision Date | March 23, 1993 |
| Days to Decision | 278 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 |