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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K162522
Device Name UltraCath Continuous Nerve block Catheter
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact James A. Cochie
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Kristen Bisanz
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
CAZ  
Date Received09/09/2016
Decision Date 03/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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