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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 K041981
Device Name GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004
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 Received07/23/2004
Decision Date 08/20/2004
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
Recalls CDRH Recalls
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