FDA 510(k) Application Details - K142333

Device Classification Name Accessories, Pump, Infusion

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510(K) Number K142333
Device Name Accessories, Pump, Infusion
Applicant AMERICAN I.V. PRODUCTS, INC dba AIV, INC
7485 SHIPLEY AVE
HARMANS, MD 21077 US
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Contact SHANNON HOUCHEN
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Regulation Number 880.5725

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Classification Product Code MRZ
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Date Received 08/21/2014
Decision Date 12/18/2014
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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