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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 K101274
Device Name VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
Applicant
Maquet Cardiovascular, LLC
170 Baytech Dr.
San Jose,  CA  95134
Applicant Contact MARK H SMITH
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/06/2010
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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