FDA 510(k) Application Details - K032789

Device Classification Name Pump, Infusion

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510(K) Number K032789
Device Name Pump, Infusion
Applicant AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER, MD 21076 US
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Contact GREGORY FALK
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 09/08/2003
Decision Date 10/09/2003
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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