FDA 510(k) Application Details - K991668

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K991668
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS, MN 55440 US
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Contact ROBERT J LANG
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 05/14/1999
Decision Date 07/26/1999
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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