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FDA 510(k) Application Details - K011261
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K011261
Device Name
Catheter, Biliary, Diagnostic
Applicant
MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE, AZ 85283 US
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Contact
SCOTT KARLER
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
04/25/2001
Decision Date
11/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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