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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 K022739
Device Name REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002
Applicant
NUCLETRON CORPORATION
7080 COLUMBIA GATEWAY DR.
COLUMBIA,  MD  21046 -2133
Applicant Contact LISA DIMMICK
Correspondent
NUCLETRON CORPORATION
7080 COLUMBIA GATEWAY DR.
COLUMBIA,  MD  21046 -2133
Correspondent Contact LISA DIMMICK
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
MUJ  
Date Received08/19/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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