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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
510(k) Number K924527
Device Name VIVUS 5000 INFUSION SYSTEM
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
FRN  
Date Received09/08/1992
Decision Date 03/29/1994
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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