FDA 510(k) Application Details - K042572

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K042572
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant KENDALL
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact BRIDGET GARDNER
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 09/21/2004
Decision Date 11/05/2004
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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