The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga.
| Device ID | K993148 |
| 510k Number | K993148 |
| Device Name: | STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA |
| Classification | Gown, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Suzanne Velazquez |
| Correspondent | Suzanne Velazquez 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 | 1999-09-21 |
| Decision Date | 1999-10-15 |