The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger Module.
| Device ID | K994053 |
| 510k Number | K994053 |
| Device Name: | STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE |
| Classification | Gown, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Susanne Velaquez |
| Correspondent | Susanne Velaquez STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-30 |
| Decision Date | 1999-12-20 |