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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 K161232
Device Name ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
Applicant
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact GWENDOLYN GEORGE
Correspondent
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact GWENDOLYN GEORGE
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
CAZ  
Date Received05/02/2016
Decision Date 09/30/2016
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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