NON-ABLATIVE WRINKLE TREATMENT HANDPIECE

Electrosurgical, Cutting & Coagulation & Accessories

ELLMAN INT'L INC.

The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Non-ablative Wrinkle Treatment Handpiece.

Pre-market Notification Details

Device IDK102368
510k NumberK102368
Device Name:NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside,  NY  11572 -3625
ContactJonathan Achenbach
CorrespondentJonathan Achenbach
ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside,  NY  11572 -3625
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-20
Decision Date2010-09-07
Summary:summary

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