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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 K964785
Device Name VERIDOSE DIODES
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Applicant Contact LINDA S MORIN
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Correspondent Contact LINDA S MORIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/29/1996
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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