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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 K080871
Device Name TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
Applicant
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Applicant Contact LISA DIMMICK
Correspondent
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Correspondent Contact LISA DIMMICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/31/2008
Decision Date 04/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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