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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 K000549
Device Name OPART, MODEL MRT-600
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Applicant Contact KEN NEHMER
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Correspondent Contact KEN NEHMER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/18/2000
Decision Date 04/20/2000
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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