FDA 510(k) Application Details - K163216

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

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510(K) Number K163216
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant C.R. Bard, Inc.
605 North 5600 West
Salt Lake City, UT 84116 US
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Contact Silvia De La Barra
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 11/16/2016
Decision Date 06/27/2017
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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