K945658 is an FDA 510(k) clearance for the INTERWOVEN(TM) REUSABLE SURGICAL GOWN. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 22, 1995, 125 days after receiving the submission on November 17, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K945658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1994 |
| Decision Date | March 22, 1995 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |