IRIDIUM 192 WIRES

Source, Wire, Iridium, Radioactive

SYNCOR INTL. CORP.

The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Iridium 192 Wires.

Pre-market Notification Details

Device IDK850163
510k NumberK850163
Device Name:IRIDIUM 192 WIRES
ClassificationSource, Wire, Iridium, Radioactive
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 CodeIWA  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-16
Decision Date1985-03-26

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