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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 K161075
Device Name Arrow Epidural Catheter Kit
Applicant
TELEFLEX MEDICAL, INC.
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Applicant Contact ANGELA BOUSE
Correspondent
TELEFLEX MEDICAL, INC.
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Correspondent Contact ANGELA BOUSE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/18/2016
Decision Date 10/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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