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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, brachytherapy, radionuclide
510(k) Number K043596
Device Name THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
Applicant
THERAGENICS CORP.
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Applicant Contact BETSY CORTELLONI
Correspondent
THERAGENICS CORP.
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Correspondent Contact BETSY CORTELLONI
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/29/2004
Decision Date 01/26/2005
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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