NUFACE, MODEL NU-4003

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Carol Cole Company

The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Nuface, Model Nu-4003.

Pre-market Notification Details

Device IDK072260
510k NumberK072260
Device Name:NUFACE, MODEL NU-4003
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Carol Cole Company 3366 N. TORREY PINES CT. SUITE 130 La Jolla,  CA  92037
ContactHoward Asher
CorrespondentHoward Asher
Carol Cole Company 3366 N. TORREY PINES CT. SUITE 130 La Jolla,  CA  92037
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-14
Decision Date2007-11-27
Summary:summary

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