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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 K833937
Device Name UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
Applicant
UNIVERSAL MEDICAL INSTRUMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
UNIVERSAL MEDICAL INSTRUMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/15/1983
Decision Date 01/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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