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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 K023883
Device Name HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest,  CA  92630
Original Contact shane noehre
Regulation Number880.5725
Classification Product Code
MEB  
Date Received11/21/2002
Decision Date 12/20/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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