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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, Teletherapy, Radionuclide
510(k) Number K964607
Device Name THERATON 1000E
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 Number892.5750
Classification Product Code
IWD  
Date Received11/18/1996
Decision Date 05/28/1997
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
Recalls CDRH Recalls
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