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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 STREET
ALAMEDA,  CA  94501
Applicant Contact BRIAN J EDWARDS
Correspondent
MONTERIS MEDICAL
1193 SHERMAN STREET
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
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