FDA 510(k) Application Details - K173155

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

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510(K) Number K173155
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact Johnathan Liu
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 09/29/2017
Decision Date 06/07/2018
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 N
Expedited Review



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