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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 K070380
Device Name PORTACLAMP FLEX
Applicant
Cardio Life Research, S.A.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
Cardio Life Research, S.A.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/08/2007
Decision Date 06/08/2007
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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