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FDA 510(k) Application Details - K162522
Device Classification Name
Catheter, Conduction, Anesthetic
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510(K) Number
K162522
Device Name
Catheter, Conduction, Anesthetic
Applicant
TELEFLEX MEDICAL , INC.
3015 Carrington Mill Blvd
Morrisville, NC 27560 US
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Contact
James A. Cochie
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Regulation Number
868.5120
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Classification Product Code
BSO
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More FDA Info for this Product Code
Date Received
09/09/2016
Decision Date
03/17/2017
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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