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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 K953028
Device Name TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
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 Number880.5725
Classification Product Code
MEB  
Date Received06/29/1995
Decision Date 09/28/1995
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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