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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 K900287
Device Name MRT 50A CRANIO-CERVICAL COIL
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Applicant Contact JAVAD SEYEDZADEH
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/22/1990
Decision Date 03/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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