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FDA 510(k) Application Details - K173110
Device Classification Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
More FDA Info for this Device
510(K) Number
K173110
Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant
Summit Medical Ltd.
Bourton Industrial Park
Bourton on the Water gl54 2hq GB
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Contact
Robyn Cochrane
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Regulation Number
868.5150
More FDA Info for this Regulation Number
Classification Product Code
BSP
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More FDA Info for this Product Code
Date Received
09/29/2017
Decision Date
05/18/2018
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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