FDA 510(k) Application Details - K083791

Device Classification Name Tube, Feeding

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510(K) Number K083791
Device Name Tube, Feeding
Applicant CORPAK MEDSYSTEMS
100 CHADDICK DR.
WHEELING, IL 60090 US
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Contact STEPHANIE WASIELEWSKI
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 12/19/2008
Decision Date 03/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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