FDA 510(k) Application Details - K050800

Device Classification Name Pump, Infusion

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510(K) Number K050800
Device Name Pump, Infusion
Applicant CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
P.O.B. 4294
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 FRN
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Date Received 03/30/2005
Decision Date 11/23/2005
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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