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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K940370
Device Name AMERICAN CATHETER E.R.C.P. CANNULA
Applicant
INTL. MEDICAL, INC.
10061 AMBERWOOD RD.
FORT MYERS,  FL  33913
Applicant Contact PETER H WETTERMANN
Correspondent
INTL. MEDICAL, INC.
10061 AMBERWOOD RD.
FORT MYERS,  FL  33913
Correspondent Contact PETER H WETTERMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/26/1994
Decision Date 08/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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