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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K932342
Device Name MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Applicant Contact ROBERT KOBISTEK
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Correspondent Contact ROBERT KOBISTEK
Classification Product Code
LNN
Date Received05/14/1993
Decision Date 12/13/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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