THE ELITE SPECTRUM

Epilator, High Frequency, Needle-type

INSTANTRON

The following data is part of a premarket notification filed by Instantron with the FDA for The Elite Spectrum.

Pre-market Notification Details

Device IDK943396
510k NumberK943396
Device Name:THE ELITE SPECTRUM
ClassificationEpilator, High Frequency, Needle-type
Applicant INSTANTRON 3124 PAWTUCKET AVE. East Providence,  RI  02915 -5195
ContactStephen A Bonzagni
CorrespondentStephen A Bonzagni
INSTANTRON 3124 PAWTUCKET AVE. East Providence,  RI  02915 -5195
Product CodeKCW  
CFR Regulation Number878.5350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-14
Decision Date1994-09-16

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