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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K112112
Device Name SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
Applicant
SENTINEL MEDICAL, INC.
555 RICHMOND STREET WEST
SUITE 800
TORONTO,  CA M5V 3B1
Applicant Contact JOAN MEDLEY
Correspondent
SENTINEL MEDICAL, INC.
555 RICHMOND STREET WEST
SUITE 800
TORONTO,  CA M5V 3B1
Correspondent Contact JOAN MEDLEY
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/25/2011
Decision Date 08/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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