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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K953754
Device Name GLOBAL HEALTHCARE FACE MASK
Applicant
Global Healthcare, Inc.
3726 K Ashford Dunwoody Rd.
Atlanta,  GA  30319
Applicant Contact ALAM AHMED
Correspondent
Global Healthcare, Inc.
3726 K Ashford Dunwoody Rd.
Atlanta,  GA  30319
Correspondent Contact ALAM AHMED
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/11/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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