FDA 510(k) Application Details - K133632

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

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510(K) Number K133632
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant B.BRAUN MEDICAL, INC
901 MARCON BLVD
ALLENTOWN, PA 18109-4962 US
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Contact LISA GIAQUINTO
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 11/26/2013
Decision Date 06/27/2014
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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