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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K171895
Device Name Grivamax Hair Growth System
Leana Orders, Inc.
431 Travis Avenue
Staten Island,  NY  10314 -6150
Applicant Contact Leonid Krits
NST Consulting, LLC
641 Shunpike Road
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
Date Received06/26/2017
Decision Date 08/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No