FDA 510(k) Application Details - K053554

Device Classification Name Pump, Infusion

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510(K) Number K053554
Device Name Pump, Infusion
Applicant MILESTONE SCIENTIFIC, INC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact HOWARD HOLSTEIN
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 12/20/2005
Decision Date 07/10/2006
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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