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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 K934739
Device Name DAVINCI CHOLANGIOGRAM DELIVERY DEVICE
Applicant
DA VINCI MEDICAL, INC.
2405 ANNAPOLIS LN.
SUITE 250
MINNEAPOLIS,  MN  55441
Applicant Contact MICHEAL A PONTIUS
Correspondent
DA VINCI MEDICAL, INC.
2405 ANNAPOLIS LN.
SUITE 250
MINNEAPOLIS,  MN  55441
Correspondent Contact MICHEAL A PONTIUS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/01/1993
Decision Date 12/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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