FDA 510(k) Application Details - K071191

Device Classification Name Tube, Feeding

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510(K) Number K071191
Device Name Tube, Feeding
Applicant NOVARTIS NUTRITION CORP.
1541 PARK PLACE BLVD.
ST. LOUIS PARK, MN 55416 US
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 04/30/2007
Decision Date 07/23/2007
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 Y
Expedited Review



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