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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 K202983
Device Name easy Hairfull
Applicant
Y&J BIO Co., Ltd.
B-916, 947, Hanam-daero
Hanam-si,  KR 12982
Applicant Contact Kwang Sic Kim
Correspondent
MDR Solutions Co., Ltd
1435 Kanjanapisek Road, Bang Khae Nuea
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/30/2020
Decision Date 12/08/2020
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
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