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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K014250
Device Name 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
Applicant
Guidant Corp.
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
N.V. Kema
P.O. Box 9035
6800 Et Arnhem
Arnhem,  NL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/26/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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