The following data is part of a premarket notification filed by Global Healthcare, Inc. with the FDA for Surgical Apparel.
| Device ID | K954549 |
| 510k Number | K954549 |
| Device Name: | SURGICAL APPAREL |
| Classification | Gown, Isolation, Surgical |
| Applicant | GLOBAL HEALTHCARE, INC. 2110 FEDERAL RD. Roswell, GA 30075 |
| Contact | Alam Ahmed |
| Correspondent | Alam Ahmed GLOBAL HEALTHCARE, INC. 2110 FEDERAL RD. Roswell, GA 30075 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-04-18 |