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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 K010549
Device Name BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
Applicant
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Applicant Contact SCOTT KARLER
Correspondent
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE,  AZ  85283
Correspondent Contact SCOTT KARLER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/26/2001
Decision Date 01/18/2002
Decision Substantially Equivalent - Kit (SESK)
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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