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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
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