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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
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