The following data is part of a premarket notification filed by Stryker Corporation with the FDA for T4/t5 Hytrel Togas.
| Device ID | K121664 |
| 510k Number | K121664 |
| Device Name: | T4/T5 HYTREL TOGAS |
| Classification | Gown, Surgical |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Casey A Metzger |
| Correspondent | Casey A Metzger STRYKER CORPORATION 4100 E. 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 | 2012-06-05 |
| Decision Date | 2014-03-10 |