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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K853671
Device Name BEAMSCAN
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received09/04/1985
Decision Date 01/10/1986
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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