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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 K963953
Device Name IMIG-MRI
Applicant
Imig-Mri Systems, LLC
300 Vesper Executive Park
Tyngsborough,  MA  01879
Applicant Contact GREGORY C HURST
Correspondent
Imig-Mri Systems, LLC
300 Vesper Executive Park
Tyngsborough,  MA  01879
Correspondent Contact GREGORY C HURST
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/02/1996
Decision Date 12/18/1996
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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