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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 K933321
Device Name DELTAMANAGER
Applicant
Medimage, Inc.
6276 Jackson Rd., Suite G
Ann Arbor,  MI  48103
Applicant Contact WILLIAM C FORGACS
Correspondent
Medimage, Inc.
6276 Jackson Rd., Suite G
Ann Arbor,  MI  48103
Correspondent Contact WILLIAM C FORGACS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/16/1993
Decision Date 11/03/1993
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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