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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 K030053
Device Name JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
Applicant
JOMED AG
15330 AVENUE OF SCIENCE
SAN DIEGO,  CA  92128
Applicant Contact TERRY SCHULTZ
Correspondent
JOMED AG
15330 AVENUE OF SCIENCE
SAN DIEGO,  CA  92128
Correspondent Contact TERRY SCHULTZ
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/23/2002
Decision Date 03/31/2003
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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