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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 K883705
Device Name FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
Applicant
Select Sources, Inc.
P.O. Box 25b01
Los Angeles,  CA  90025
Applicant Contact ALLEN S FARSHI
Correspondent
Select Sources, Inc.
P.O. Box 25b01
Los Angeles,  CA  90025
Correspondent Contact ALLEN S FARSHI
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/30/1988
Decision Date 11/14/1988
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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