VECTORSURGE 5 MODEL 470

Stimulator, Muscle, Powered

METRON MEDICAL AUSTRALIA PTY LTD

The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsurge 5 Model 470.

Pre-market Notification Details

Device IDK030648
510k NumberK030648
Device Name:VECTORSURGE 5 MODEL 470
ClassificationStimulator, Muscle, Powered
Applicant METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria,  AU 3201
ContactDave Toman
CorrespondentDave Toman
METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria,  AU 3201
Product CodeIPF  
Subsequent Product CodeGZJ
Subsequent Product CodeLIH
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-28
Decision Date2003-03-28

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