CS137 SEALED SOURCES

Source, Brachytherapy, Radionuclide

SYNCOR INTL. CORP.

The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Cs137 Sealed Sources.

Pre-market Notification Details

Device IDK850434
510k NumberK850434
Device Name:CS137 SEALED SOURCES
ClassificationSource, Brachytherapy, Radionuclide
Applicant SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar,  CA  91342
ContactEleanor V Chiu
CorrespondentEleanor V Chiu
SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar,  CA  91342
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-04
Decision Date1985-03-26

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