FDA 510(k) Application Details - K011018

Device Classification Name Catheter, Biliary, Surgical

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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
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Regulation Number 876.5010

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Classification Product Code GCA
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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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