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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System Accessories, Extracorporeal
510(k) Number K853536
Device Name VELCRO FISTULA PRESSURE CLAMPS
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 Number876.5820
Classification Product Code
KXM  
Date Received08/23/1985
Decision Date 10/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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