The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker T6 Hoods And Togas.
| Device ID | K063005 |
| 510k Number | K063005 |
| Device Name: | STRYKER T6 HOODS AND TOGAS |
| Classification | Gown, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Paulette D Johnson |
| Correspondent | Paulette D Johnson STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2007-03-23 |
| Summary: | summary |