LAWRENCE CSERION, MODEL CS-1

Source, Brachytherapy, Radionuclide

ISORAY, INC

The following data is part of a premarket notification filed by Isoray, Inc with the FDA for Lawrence Cserion, Model Cs-1.

Pre-market Notification Details

Device IDK030162
510k NumberK030162
Device Name:LAWRENCE CSERION, MODEL CS-1
ClassificationSource, Brachytherapy, Radionuclide
Applicant ISORAY, INC 350 HILLS ST. SUITE 106 Richland,  WA  99352
ContactDavid Swanberg
CorrespondentDavid Swanberg
ISORAY, INC 350 HILLS ST. SUITE 106 Richland,  WA  99352
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-16
Decision Date2003-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000064576 K030162 000
00860000064569 K030162 000

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