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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 K980653
Device Name PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
Applicant
CORDIS CORP.
35 & 40 TECHNOLOGY DR.
WARREN,  NJ  07059
Applicant Contact CHARLES J RYAN
Correspondent
CORDIS CORP.
35 & 40 TECHNOLOGY DR.
WARREN,  NJ  07059
Correspondent Contact CHARLES J RYAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/11/1998
Decision Date 06/09/1998
Decision Substantially Equivalent (SESE)
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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