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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 K901431
Device Name TELEMED ERCP CANNULA
Applicant
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Applicant Contact JOHN A CHAVES
Correspondent
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Correspondent Contact JOHN A CHAVES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/26/1990
Decision Date 06/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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