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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 K984063
Device Name PARAGON BASAL/BOLUS ADMINISTRATION SET
Applicant
I-Flow Corp.
20202 Windrow Dr.
Lake Forest,  CA  92630
Applicant Contact ROBERT J BARD
Correspondent
I-Flow Corp.
20202 Windrow Dr.
Lake Forest,  CA  92630
Correspondent Contact ROBERT J BARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/16/1998
Decision Date 02/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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