CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.

System, Applicator, Radionuclide, Manual

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Cesium-137 Afterloading System /gyn.bra..

Pre-market Notification Details

Device IDK800320
510k NumberK800320
Device Name:CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
ClassificationSystem, Applicator, Radionuclide, Manual
Applicant AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIWJ  
CFR Regulation Number892.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-12
Decision Date1980-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.