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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Radiographic
510(k) Number K925705
Device Name ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
Applicant
Denar Corp.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
Denar Corp.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number892.1920
Classification Product Code
IWY  
Date Received11/12/1992
Decision Date 12/28/1992
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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