FDA 510(k) Application Details - K072476

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K072476
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact VIRGINIA CARR
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 09/04/2007
Decision Date 12/14/2007
Decision SESK - SUBST EQUIV - KIT
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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