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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 K910006
Device Name AVD INTIMAX (TM) BILIARY CATHETER
Applicant
APPLIED VASCULAR
26051 MERIT CIRCLE
BUILDING 104
LAUNA HILLS,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
APPLIED VASCULAR
26051 MERIT CIRCLE
BUILDING 104
LAUNA HILLS,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/02/1991
Decision Date 02/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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