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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test-Pattern, Radiographic
510(k) Number K865100
Device Name TISSUE-EQUIVALENT BREAST SIMULATOR
Applicant
Computerized Imaging Reference Systems, Inc.
2488b Almeda Ave.
Norfolk,  VA  23513
Applicant Contact WILLIAM R DRURY
Correspondent
Computerized Imaging Reference Systems, Inc.
2488b Almeda Ave.
Norfolk,  VA  23513
Correspondent Contact WILLIAM R DRURY
Regulation Number892.1940
Classification Product Code
IXF  
Date Received12/30/1986
Decision Date 01/12/1987
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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