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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 K131249
Device Name ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
Applicant
I-FLOW LLC
43 Discovery Suite 100
Irvine,  CA  92618
Applicant Contact SHELLY HARRIS
Correspondent
I-FLOW LLC
43 Discovery Suite 100
Irvine,  CA  92618
Correspondent Contact SHELLY HARRIS
Regulation Number880.5725
Classification Product Code
MEB  
Date Received05/01/2013
Decision Date 02/03/2014
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
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