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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 K022718
Device Name VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
N.V. KEMA
P.O. BOX 9035
6800 ET ARNHEM
ARNHEM,  NL
Correspondent Contact PETER N RUYS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/15/2002
Decision Date 08/28/2002
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
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