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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 K182562
Device Name Hair Boom 69
Applicant
Wontech
64 Techno 8-Ro, Yuseong-Gu
Daejeon,  KR 305-500
Applicant Contact Gyuri (Erin) Park
Correspondent
Nst Consultants, Inc.
642 Shunpike Rd., Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/18/2018
Decision Date 11/16/2018
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
Predetermined Change
Control Plan Authorized		 No
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