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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 K132444
Device Name ATAMA SYSTEM
Applicant
Monteris Medical,
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact BRIAN J EDWARDS
Correspondent
Monteris Medical,
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact BRIAN J EDWARDS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/06/2013
Decision Date 01/27/2014
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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