FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS

Source, Calibration, Sealed, Nuclear

SYNCOR INTL. CORP.

The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Flood Sources & Dose Calibrators W/various Nuclids.

Pre-market Notification Details

Device IDK850208
510k NumberK850208
Device Name:FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
ClassificationSource, Calibration, Sealed, Nuclear
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 CodeIXD  
CFR Regulation Number892.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-18
Decision Date1985-03-26

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