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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 K935811
Device Name BOLUS DISPENSER
Applicant
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Applicant Contact ROBERT J BARD
Correspondent
I-Flow Corp.
2532 White Rd.
Irvine,  CA  92714
Correspondent Contact ROBERT J BARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/02/1993
Decision Date 01/20/1995
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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