Legacy BX

Electrosurgical, Cutting & Coagulation & Accessories

Venus Concept USA Inc.

The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Legacy Bx.

Pre-market Notification Details

Device IDK142910
510k NumberK142910
Device Name:Legacy BX
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Venus Concept USA Inc. 4556 N Hiatus Road Sunrise,  FL  33351
ContactLilia Schlosberg
CorrespondentAhava Stein
A. Stein - Regulatory Affairs Consulting Ltd. 175 Derby St., Unit 27 Suite 1 Hingham,  MA  02043
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-06
Decision Date2014-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016541533 K142910 000
07290016541472 K142910 000
07290016540086 K142910 000

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