K982694 is an FDA 510(k) clearance for the MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 14, 1998, 133 days after receiving the submission on August 3, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K982694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1998 |
| Decision Date | December 14, 1998 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |