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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 K063530
FOIA Releasable 510(k) K063530
Device Name ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
Applicant
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Applicant Contact JAMES J DAL PORTO
Correspondent
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Correspondent Contact JAMES J DAL PORTO
Regulation Number880.5725
Classification Product Code
MEB  
Date Received11/22/2006
Decision Date 01/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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