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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 K984638
FOIA Releasable 510(k) K984638
Device Name PARAGON BOLUS ACCESSORY 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 Received12/31/1998
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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