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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 K922276
Device Name THERAC 25
Applicant
Theratronics, Inc.
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Applicant Contact JAMES M HOWARD
Correspondent
Theratronics, Inc.
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent Contact JAMES M HOWARD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/15/1992
Decision Date 05/25/1994
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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