K040764 is an FDA 510(k) clearance for the STRYKER T4 HYTREL ZIPPER TOGA. 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 April 27, 2004, 33 days after receiving the submission on March 25, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K040764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2004 |
| Decision Date | April 27, 2004 |
| Days to Decision | 33 days |
| Submission Type | Special |
| 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 |