K914369 is an FDA 510(k) clearance for the QUALTEX MAGNETIC INSTRUMENT DRAPE. 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 December 2, 1991, 62 days after receiving the submission on October 1, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K914369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1991 |
| Decision Date | December 02, 1991 |
| Days to Decision | 62 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 |