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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name graft, vascular, synthetic/biologic composite
510(k) Number K122612
Device Name HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
Applicant
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne,  NJ  07470
Applicant Contact marylou insinga
Correspondent
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne,  NJ  07470
Correspodent Contact marylou insinga
Regulation Number870.3450
Classification Product Code
MAL  
Date Received08/27/2012
Decision Date 09/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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