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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 K941418
Device Name INFUSION PUMP
Applicant
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Applicant Contact ROBERT J BRAD, J.D
Correspondent
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Correspondent Contact ROBERT J BRAD, J.D
Regulation Number880.5725
Classification Product Code
MEB  
Date Received03/23/1994
Decision Date 07/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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