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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 K050301
Device Name MRIDIUM 3850 MRI PUMP 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 Received02/08/2005
Decision Date 03/24/2005
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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