IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES

System, Applicator, Radionuclide, Manual

BEST INDUSTRIES

The following data is part of a premarket notification filed by Best Industries with the FDA for Implant Applicators, Cartridges/magazines, Implanters For Permanent Implant Of Radioactive Seeds/sources.

Pre-market Notification Details

Device IDK933410
510k NumberK933410
Device Name:IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
ClassificationSystem, Applicator, Radionuclide, Manual
Applicant BEST INDUSTRIES 7643 FULLERTON RD. Springfield,  VA  22153
ContactSankara I Ramaswamy
CorrespondentSankara I Ramaswamy
BEST INDUSTRIES 7643 FULLERTON RD. Springfield,  VA  22153
Product CodeIWJ  
CFR Regulation Number892.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-15
Decision Date1994-12-30

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