1-125 ENDOSEED

Source, Brachytherapy, Radionuclide

ENDO TECHNIC CORP.

The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for 1-125 Endoseed.

Pre-market Notification Details

Device IDK914825
510k NumberK914825
Device Name:1-125 ENDOSEED
ClassificationSource, Brachytherapy, Radionuclide
Applicant ENDO TECHNIC CORP. 4340 LEAVENWORTH Omaha,  NE  68105
ContactRoger Good
CorrespondentRoger Good
ENDO TECHNIC CORP. 4340 LEAVENWORTH Omaha,  NE  68105
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-28
Decision Date1992-03-19

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