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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 K021533
Device Name DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
Applicant
Creative Contract (M) Sdn Bhd
8220 Charles Page Blvd.
Sand Springs,  OK  74063
Applicant Contact MARK REIBER
Correspondent
Creative Contract (M) Sdn Bhd
8220 Charles Page Blvd.
Sand Springs,  OK  74063
Correspondent Contact MARK REIBER
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/10/2002
Decision Date 03/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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