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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K850416
Device Name TOMOMATIC 564
Applicant
M.I.D., Inc.
18103 Sky Park S. D-205
Irvine,  CA  92714
Applicant Contact JORGEN MADSEN
Correspondent
M.I.D., Inc.
18103 Sky Park S. D-205
Irvine,  CA  92714
Correspondent Contact JORGEN MADSEN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/04/1985
Decision Date 09/20/1985
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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