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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 K030512
Device Name GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact NANCY LINCE
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact NANCY LINCE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/19/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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