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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K940657
Device Name IV BAG PUMP
Applicant
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Applicant Contact ROBERT J BARD, PH.D
Correspondent
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Correspondent Contact ROBERT J BARD, PH.D
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Codes
KZD   MEB  
Date Received02/15/1994
Decision Date 02/03/1995
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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