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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 K110411
Device Name ATAMA SYSTEM
Applicant
MONTERIS MEDICAL, INC.
100 - 78 Innovation Drive
Winnipeg,  CA R3T 6C2
Applicant Contact JEFF WILSON
Correspondent
MONTERIS MEDICAL, INC.
100 - 78 Innovation Drive
Winnipeg,  CA R3T 6C2
Correspondent Contact JEFF WILSON
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/14/2011
Decision Date 04/08/2011
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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