OMNITRON GYN APPLICATOR SYSTEM

System, Applicator, Radionuclide, Remote-controlled

OMNITRON INTL., INC.

The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnitron Gyn Applicator System.

Pre-market Notification Details

Device IDK913908
510k NumberK913908
Device Name:OMNITRON GYN APPLICATOR SYSTEM
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston,  TX  77054
ContactLisa S Jones
CorrespondentLisa S Jones
OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston,  TX  77054
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-30
Decision Date1992-03-06

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