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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 K901433
Device Name SURE-FLEX ANASTOMOTIC BALLOON DILATOR
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  
Subsequent Product Code
KNQ  
Date Received03/26/1990
Decision Date 06/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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