FDA 510(k) Application Details - K040957

Device Classification Name Pump, Infusion, Enteral

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510(K) Number K040957
Device Name Pump, Infusion, Enteral
Applicant CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
INDUSTRIAL PARK
CAESAREA 38900 IL
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Contact GALI TZURY
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Regulation Number 880.5725

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Classification Product Code LZH
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Date Received 04/13/2004
Decision Date 05/21/2004
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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