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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 K031360
Device Name GI SUPPLY BILIARY STENT
Applicant
GI SUPPLY
25 VILLAGE HILL ROAD
WILLINGTON,  CT  06279
Applicant Contact ROB WHALEN
Correspondent
GI SUPPLY
25 VILLAGE HILL ROAD
WILLINGTON,  CT  06279
Correspondent Contact ROB WHALEN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/30/2003
Decision Date 09/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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