FDA 510(k) Application Details - K030855

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K030855
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact PAIGE SWEENEY
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 03/18/2003
Decision Date 04/17/2003
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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