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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 K010714
Device Name EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
Applicant
MEDI-GLOBE CORP.
MEDI-GLOB-STRASSE 1-5
ACHENMUHLE,  DE
Applicant Contact GERHARDT SEIWERTH
Correspondent
MEDI-GLOBE CORP.
MEDI-GLOB-STRASSE 1-5
ACHENMUHLE,  DE
Correspondent Contact GERHARDT SEIWERTH
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received03/09/2001
Decision Date 01/21/2003
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
Predetermined Change
Control Plan Authorized		 No
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