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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K153194
Device Name VASOVIEW HemoPro Endoscopic Vessel Harvesting System
Applicant
MAQUET CARDIOVASCULAR, LLC
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact MARK DINGER
Correspondent
MAQUET CARDIOVASCULAR, LLC
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact MARK DINGER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/04/2015
Decision Date 04/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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