FDA 510(k) Application Details - K950017

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K950017
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant ROSS PRODUCTS
625 CLEVELAND AVE.
COLUMBUS, OH 43215-1724 US
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Contact MICHAEWL H HANEY
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 01/03/1995
Decision Date 03/14/1997
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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