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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
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