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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 K110802
Device Name A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
Applicant
Esaote, S.P.A.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact Allison Scott
Correspondent
Esaote, S.P.A.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Correspondent Contact Allison Scott
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/23/2011
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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