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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 K802809
Device Name ELECTRON ARC THERAPY
Applicant
Varian Assoc., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Varian Assoc., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/07/1980
Decision Date 01/07/1981
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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