K964142 is an FDA 510(k) clearance for the MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 25, 1997, 132 days after receiving the submission on October 16, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K964142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1996 |
| Decision Date | February 25, 1997 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |