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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 K023210
Device Name SEEDLINKS, MODELS 70301, 70302, 70303
Applicant
Sourcetech Medical, LLC
295 E. Lies Rd.
Carol Stream,  IL  60188
Applicant Contact DAVID T SIERACKI
Correspondent
Sourcetech Medical, LLC
295 E. Lies Rd.
Carol Stream,  IL  60188
Correspondent Contact DAVID T SIERACKI
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/26/2002
Decision Date 03/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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