K993148 is an FDA 510(k) clearance for the STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 15, 1999, 24 days after receiving the submission on September 21, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K993148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1999 |
| Decision Date | October 15, 1999 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |