The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Flyte Hybrid Hood, Flyte Hybrid Hood With Peelaway Lens.
| Device ID | K140588 |
| 510k Number | K140588 |
| Device Name: | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS |
| Classification | Hood, Surgical |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Julia Helgeson |
| Correspondent | Julia Helgeson STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Product Code | FXY |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-07 |
| Decision Date | 2014-06-26 |
| Summary: | summary |