The following data is part of a premarket notification filed by Global Healthcare, Inc. with the FDA for Global Healthcare Face Mask.
| Device ID | K953754 |
| 510k Number | K953754 |
| Device Name: | GLOBAL HEALTHCARE FACE MASK |
| Classification | Mask, Surgical |
| Applicant | GLOBAL HEALTHCARE, INC. 3726 K ASHFORD DUNWOODY RD. Atlanta, GA 30319 |
| Contact | Alam Ahmed |
| Correspondent | Alam Ahmed GLOBAL HEALTHCARE, INC. 3726 K ASHFORD DUNWOODY RD. Atlanta, GA 30319 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-11 |
| Decision Date | 1996-01-26 |