K944393 is an FDA 510(k) clearance for the STRYKER STERI-SHIELD SURGICAL APPAREL. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 28, 1995, 353 days after receiving the submission on September 9, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K944393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1994 |
| Decision Date | August 28, 1995 |
| Days to Decision | 353 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 |