FDA 510(k) Application Details - K023863

Device Classification Name Pump, Infusion

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510(K) Number K023863
Device Name Pump, Infusion
Applicant HELP TECHNOLOGIES
24312 ARMADA DR.
DANA POINT, CA 92629 US
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Contact ROBERT J BARD
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 11/20/2002
Decision Date 02/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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