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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 K052274
Device Name GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
Applicant
GUIDANT CORPORATION
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact M. LAURIE WONG
Correspondent
GUIDANT CORPORATION
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact M. LAURIE WONG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/22/2005
Decision Date 09/21/2005
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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