K934664 is an FDA 510(k) clearance for the HYDRAGOWN. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 24, 1994, 238 days after receiving the submission on September 28, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K934664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1993 |
| Decision Date | May 24, 1994 |
| Days to Decision | 238 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 |