AFTER LOADING DEVICE KIT

System, Applicator, Radionuclide, Manual

MEDICAL RADIATION DEVICES, INC.

The following data is part of a premarket notification filed by Medical Radiation Devices, Inc. with the FDA for After Loading Device Kit.

Pre-market Notification Details

Device IDK893703
510k NumberK893703
Device Name:AFTER LOADING DEVICE KIT
ClassificationSystem, Applicator, Radionuclide, Manual
Applicant MEDICAL RADIATION DEVICES, INC. P.O. BOX 6762 Dothan,  AL  36302
ContactWilliam Kan
CorrespondentWilliam Kan
MEDICAL RADIATION DEVICES, INC. P.O. BOX 6762 Dothan,  AL  36302
Product CodeIWJ  
CFR Regulation Number892.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-18
Decision Date1989-09-18

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