K200493 is an FDA 510(k) clearance for the Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover. This device is classified as a Hood, Surgical (Class II - Special Controls, product code FXY).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 21, 2020, 22 days after receiving the submission on February 28, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K200493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2020 |
| Decision Date | March 21, 2020 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXY — Hood, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |