K894764 is an FDA 510(k) clearance for the OR TOWEL PACKS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on August 18, 1989, 22 days after receiving the submission on July 27, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K894764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1989 |
| Decision Date | August 18, 1989 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |