GLOBAL HEALTHCARE FACE MASK

Mask, Surgical

GLOBAL HEALTHCARE, INC.

The following data is part of a premarket notification filed by Global Healthcare, Inc. with the FDA for Global Healthcare Face Mask.

Pre-market Notification Details

Device IDK953754
510k NumberK953754
Device Name:GLOBAL HEALTHCARE FACE MASK
ClassificationMask, Surgical
Applicant GLOBAL HEALTHCARE, INC. 3726 K ASHFORD DUNWOODY RD. Atlanta,  GA  30319
ContactAlam Ahmed
CorrespondentAlam Ahmed
GLOBAL HEALTHCARE, INC. 3726 K ASHFORD DUNWOODY RD. Atlanta,  GA  30319
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-11
Decision Date1996-01-26

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