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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 K940237
Device Name THERAPLAN V05B/ TP-11 V09B
Applicant
Theratronics, Inc.
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Applicant Contact E. S. MARTELL
Correspondent
Theratronics, Inc.
413 March Rd.
P.O. Box 13140
Kanata, Ontario, Canada,  CA K2K 2B7
Correspondent Contact E. S. MARTELL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/18/1994
Decision Date 07/26/1994
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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