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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K020143
Device Name VASOVIEW 5 HARVESTING CANNULA
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 Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GEI  
Date Received01/16/2002
Decision Date 02/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
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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