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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 K092352
Device Name SCUBA BILIARY STENT SYSTEM
Applicant
INVATEC S.P.A.
3101 EMRICK BLVD
BETHLEHEM,  PA  18020
Applicant Contact STEVE CAMP
Correspondent
INVATEC S.P.A.
3101 EMRICK BLVD
BETHLEHEM,  PA  18020
Correspondent Contact STEVE CAMP
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/04/2009
Decision Date 03/16/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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