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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 K143164
Device Name ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
Applicant
Kimberly-Clark Corporation
43 Discovery
Suite 100
Irvine,  CA  92618
Applicant Contact MARIA E WAGNER
Correspondent
Kimberly-Clark Corporation
43 Discovery
Suite 100
Irvine,  CA  92618
Correspondent Contact MARIA E WAGNER
Regulation Number868.5120
Classification Product Code
BSO  
Date Received11/03/2014
Decision Date 12/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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