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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 K091733
Device Name VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
Applicant
Maquet Cardiovascular, LLC
170 Baytech Dr.
San Jose,  CA  95134
Applicant Contact ARTIE KAUSHIK
Correspondent
Maquet Cardiovascular, LLC
170 Baytech Dr.
San Jose,  CA  95134
Correspondent Contact ARTIE KAUSHIK
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GBX  
Date Received06/11/2009
Decision Date 08/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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