FDA 510(k) Application Details - K072005

Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)

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510(K) Number K072005
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant EPIMED INTERNATIONAL
141 SAL LANDRIO DR.
JOHNSTOWN, NY 12095 US
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Contact KATIE ALEXANDER
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 07/23/2007
Decision Date 02/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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