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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 K090087
Device Name MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
Applicant
IRADIMED CORPORATION
7457 ALOMA AVE., SUITE 201
WINTER PARK,  FL  32792
Applicant Contact FRANCIS X CASEY
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/13/2009
Decision Date 04/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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