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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K123571
Device Name CARDIO VISION MICS AORTIC CLAMPS
Applicant
Cardiomedical GmbH
Amstel 320-1
Amsterdam,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Cardiomedical GmbH
Amstel 320-1
Amsterdam,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number870.4450
Classification Product Code
DXC  
Date Received11/20/2012
Decision Date 08/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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