125 IMPLANT SEEDS, MODEL STM1251

Source, Brachytherapy, Radionuclide

SOURCETECH MEDICAL, L.L.C.

The following data is part of a premarket notification filed by Sourcetech Medical, L.l.c. with the FDA for 125 Implant Seeds, Model Stm1251.

Pre-market Notification Details

Device IDK991280
510k NumberK991280
Device Name:125 IMPLANT SEEDS, MODEL STM1251
ClassificationSource, Brachytherapy, Radionuclide
Applicant SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream,  IL  60188
ContactDavid T Sieracki
CorrespondentDavid T Sieracki
SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream,  IL  60188
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-14
Decision Date1999-10-20

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