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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 K003365
Device Name S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact SAM MIRZA
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact SAM MIRZA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/27/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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