K864388 is an FDA 510(k) clearance for the MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY. 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 February 20, 1987, 106 days after receiving the submission on November 6, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K864388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1986 |
| Decision Date | February 20, 1987 |
| Days to Decision | 106 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 |