FDA 510(k) Application Details - K990863

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K990863
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS, OH 43215-1724 US
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Contact DANIEL HAMILTON
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 03/16/1999
Decision Date 04/06/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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