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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 K890799
Device Name CURIETRON 192 HIGH DOSE RATE
Applicant
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Applicant Contact RITA T MCCULLOUGH
Correspondent
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Correspondent Contact RITA T MCCULLOUGH
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received02/17/1989
Decision Date 10/27/1989
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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