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FDA 510(k) Application Details - K011018
Device Classification Name
Catheter, Biliary, Surgical
More FDA Info for this Device
510(K) Number
K011018
Device Name
Catheter, Biliary, Surgical
Applicant
TAUT, INC.
2571 KANEVILLE COURT
GENEVA, IL 60134 US
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Contact
RON KENSETH
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
GCA
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More FDA Info for this Product Code
Date Received
04/04/2001
Decision Date
06/22/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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