K994053 is an FDA 510(k) clearance for the STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE. 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 December 20, 1999, 20 days after receiving the submission on November 30, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K994053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1999 |
| Decision Date | December 20, 1999 |
| Days to Decision | 20 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 |