FDA 510(k) Application Details - K050107

Device Classification Name Pump, Infusion

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510(K) Number K050107
Device Name Pump, Infusion
Applicant HARVARD CLINICAL TECHNOLOGY
22 PLEASANT ST.
SOUTH NATICK, MA 01760 US
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Contact ERIC J FLACHBART
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 01/18/2005
Decision Date 02/11/2005
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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