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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 K031353
Device Name SOLUTION FACE MASKS
Applicant
A PLUS INTERNATIONAL, INC
5138 EUCALYPTUS AVE.
CHINO,  CA  91710
Applicant Contact SOLOMON CHEN
Correspondent
CALIFORNIA DEPARTMENT OF HEALTH SERVICES
P.O. BOX 942732 (MS-357)
SACRAMENTO,  CA  94234 -7320
Correspondent Contact ALFREDO J QUATTRONE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/29/2003
Decision Date 06/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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