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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 K072296
Device Name POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
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 Received08/17/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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