Grivamax Hair Growth System

Laser, Comb, Hair

Leana Orders, Inc.

The following data is part of a premarket notification filed by Leana Orders, Inc. with the FDA for Grivamax Hair Growth System.

Pre-market Notification Details

Device IDK171895
510k NumberK171895
Device Name:Grivamax Hair Growth System
ClassificationLaser, Comb, Hair
Applicant Leana Orders, Inc. 431 Travis Avenue Staten Island,  NY  10314 -6150
ContactLeonid Krits
CorrespondentRaymond R. Blanche
NST Consulting, LLC 641 Shunpike Road Chatham,  NJ  07928
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-26
Decision Date2017-08-22
Summary:summary

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