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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 K113394
Device Name MAVRIC SL
Applicant
Ge Medical Systems, LLC
3200 N.Grandview Blvd.
W-828
Waukesha,  WI  53188
Applicant Contact YUAN MA
Correspondent
Ge Medical Systems, LLC
3200 N.Grandview Blvd.
W-828
Waukesha,  WI  53188
Correspondent Contact YUAN MA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/16/2011
Decision Date 12/11/2012
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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