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 |