The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker T4 Hytrel (r) Togas.
| Device ID | K011755 |
| 510k Number | K011755 |
| Device Name: | STRYKER T4 HYTREL (R) TOGAS |
| Classification | Accessory, Surgical Apparel |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Suzanne Velasquez |
| Correspondent | Suzanne Velasquez STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-06 |
| Decision Date | 2001-06-22 |