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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K153652
Device Name ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
Applicant
Teleflex, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact CHET JONES
Correspondent
Teleflex, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact CHET JONES
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received12/21/2015
Decision Date 06/21/2016
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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