K070078 is an FDA 510(k) clearance for the STRYKER T4 HYTREL TOGA. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on February 2, 2007, 24 days after receiving the submission on January 9, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K070078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2007 |
| Decision Date | February 02, 2007 |
| Days to Decision | 24 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 |