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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 K023318
Device Name I-FLOW ELASTOMERIC PUMP WITH BOLUS
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest,  CA  92630
Original Contact shane noehre
Regulation Number880.5725
Classification Product Code
MEB  
Date Received10/04/2002
Decision Date 10/18/2002
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
Recalls CDRH Recalls
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