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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K874214
Device Name S9 DISPLAY SYSTEM
Applicant
O.M.I. Oncology Microsystems, Inc.
2232 Tashy Place
Victoria, B.C.
Canada,  CA V8N 4R6
Applicant Contact MORRIS, PH.D.
Correspondent
O.M.I. Oncology Microsystems, Inc.
2232 Tashy Place
Victoria, B.C.
Canada,  CA V8N 4R6
Correspondent Contact MORRIS, PH.D.
Regulation Number892.5900
Classification Product Code
JAD  
Date Received10/16/1987
Decision Date 02/22/1988
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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