FDA 510(k) Application Details - K001879

Device Classification Name Kit, I.V. Start

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510(K) Number K001879
Device Name Kit, I.V. Start
Applicant NIRVI INTL. USA
467 DIABLO DR.
PITTSBURG, PA 15241 US
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Contact DARSHANA HATHI
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Regulation Number 000.0000

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Classification Product Code LRS
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Date Received 06/20/2000
Decision Date 11/20/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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