DAPELLE HAIR REMOVER

Epilator, High Frequency, Tweezer-type

WELLQUEST INTL., INC.

The following data is part of a premarket notification filed by Wellquest Intl., Inc. with the FDA for Dapelle Hair Remover.

Pre-market Notification Details

Device IDK973773
510k NumberK973773
Device Name:DAPELLE HAIR REMOVER
ClassificationEpilator, High Frequency, Tweezer-type
Applicant WELLQUEST INTL., INC. 230 FIFTH AVE, New York,  NY  10001
ContactSteven Mishan
CorrespondentSteven Mishan
WELLQUEST INTL., INC. 230 FIFTH AVE, New York,  NY  10001
Product CodeKCX  
CFR Regulation Number878.5360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-02
Decision Date1997-12-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.