K030365 is an FDA 510(k) clearance for the DEROYAL DRAPES, STERILE, NON-STERILE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 29, 2003, 84 days after receiving the submission on February 4, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K030365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2003 |
| Decision Date | April 29, 2003 |
| Days to Decision | 84 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 |