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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 K920236
Device Name CHOLANGIOGRAM CATHETER KIT
Applicant
Mccol Medical,Inc.
9406 S. 46th St.
Phoenix,  AZ  85044
Applicant Contact WILLIAM M COLONE
Correspondent
Mccol Medical,Inc.
9406 S. 46th St.
Phoenix,  AZ  85044
Correspondent Contact WILLIAM M COLONE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/17/1992
Decision Date 05/06/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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