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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 K990990
Device Name CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
Applicant
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact RALPH E SHUPING
Correspondent
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact RALPH E SHUPING
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/24/1999
Decision Date 10/07/1999
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
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