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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K915622
Device Name PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
Applicant
Nucletron-Oldelft Corp.
9160 Redbranch Rd.
Columbia,  MD  21045
Applicant Contact A. M MOUNT
Correspondent
Nucletron-Oldelft Corp.
9160 Redbranch Rd.
Columbia,  MD  21045
Correspondent Contact A. M MOUNT
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received12/16/1991
Decision Date 09/25/1992
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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