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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K101295
Device Name MROPEN
Applicant
Paramed S.R.L.
39 High St.
North Andover,  MA  01845
Applicant Contact RICHARD R GLASHEEN
Correspondent
Paramed S.R.L.
39 High St.
North Andover,  MA  01845
Correspondent Contact RICHARD R GLASHEEN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/10/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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