FDA 510(k) Application Details - K003047

Device Classification Name Pump, Infusion, Enteral

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510(K) Number K003047
Device Name Pump, Infusion, Enteral
Applicant ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS, OH 43215-1724 US
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Contact YUKA HENDERSHOT
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Regulation Number 880.5725

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Classification Product Code LZH
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Date Received 09/29/2000
Decision Date 06/12/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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