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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
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest,  CA  92630
Original 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
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