FDA 510(k) Application Details - K042085

Device Classification Name Pump, Infusion

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510(K) Number K042085
Device Name Pump, Infusion
Applicant CANE S.R.L.
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 08/03/2004
Decision Date 09/17/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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