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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 K983154
Device Name CYSTIC DUCT BALLOON DILATING CATHETER
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact HOWARD V ROWE
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact HOWARD V ROWE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/09/1998
Decision Date 05/05/1999
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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