FDA 510(k) Application Details - K142922

Device Classification Name Choledochoscope And Accessories, Flexible/Rigid

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510(K) Number K142922
Device Name Choledochoscope And Accessories, Flexible/Rigid
Applicant BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact CARTER NAVARRO
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Regulation Number 876.1500

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Classification Product Code FBN
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Date Received 10/08/2014
Decision Date 01/16/2015
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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