The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Steri-shield Surgical Apparel.
| Device ID | K944393 |
| 510k Number | K944393 |
| Device Name: | STRYKER STERI-SHIELD SURGICAL APPAREL |
| Classification | Gown, Surgical |
| Applicant | STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Contact | Tammy Louds |
| Correspondent | Tammy Louds STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-09 |
| Decision Date | 1995-08-28 |