FDA 510(k) Application Details - K061325

Device Classification Name Pump, Infusion

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510(K) Number K061325
Device Name Pump, Infusion
Applicant CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
CAESAREA INDUSTRIAL PARK
CAESAREA 38900 IL
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Contact SHLOMI DINES
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 05/11/2006
Decision Date 08/24/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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