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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K931927
Device Name VICTOREEN MODEL 530
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Applicant Contact ROBERT J KOBISTEK
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Correspondent Contact ROBERT J KOBISTEK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/16/1993
Decision Date 11/15/1993
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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