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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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More FDA Info for this Product Code
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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