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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K181360
Device Name ON-Q* Pump with Bolus
Applicant
Halyard Health
43 Discovery
Suite 100
Irvine,  CA  92618
Applicant Contact Neerav Parikh
Correspondent
Halyard Health
43 Discovery
Suite 100
Irvine,  CA  92618
Correspondent Contact Neerav Parikh
Regulation Number880.5725
Classification Product Code
MEB  
Date Received05/22/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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