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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
510(k) Number K022869
FOIA Releasable 510(k) K022869
Device Name SOAKER CATHETER
Applicant
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Applicant Contact SHANE NOEHRE
Correspondent
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Correspondent Contact SHANE NOEHRE
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MRZ  
Date Received08/29/2002
Decision Date 09/20/2002
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
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