FDA 510(k) Application Details - K091340

Device Classification Name Tube, Feeding

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510(K) Number K091340
Device Name Tube, Feeding
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact Marybeth Gamber
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 05/06/2009
Decision Date 06/09/2009
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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