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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tourniquet, nonpneumatic
510(k) Number K853537
Device Name VELCRO TOURNIQUET
Applicant
CP MEDICAL
1775 WHITTIER AVE.
COSTA MESA,  CA  92627
Applicant Contact CARL GRODACH
Correspondent
CP MEDICAL
1775 WHITTIER AVE.
COSTA MESA,  CA  92627
Correspondent Contact CARL GRODACH
Regulation Number878.5900
Classification Product Code
GAX  
Date Received08/23/1985
Decision Date 09/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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