The following data is part of a premarket notification filed by Stryker Instruments, Instruments Div. with the FDA for Stryker Stri-shield Flyte Togas.
| Device ID | K073017 |
| 510k Number | K073017 |
| Device Name: | STRYKER STRI-SHIELD FLYTE TOGAS |
| Classification | Gown, Surgical |
| Applicant | STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Paulette D Johnson |
| Correspondent | Paulette D Johnson STRYKER INSTRUMENTS, INSTRUMENTS DIV. 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 | 2007-10-25 |
| Decision Date | 2007-11-30 |
| Summary: | summary |