FDA 510(k) Application Details - K131590

Device Classification Name Tube, Feeding

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510(K) Number K131590
Device Name Tube, Feeding
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER, MA 01810 US
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Contact CHRISTINE TREFETHEN
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 05/31/2013
Decision Date 10/23/2013
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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