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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K213557
Device Name Finexel
Applicant
Snj Co., Ltd.
#604, Ace-Techno Tower 2, Digital Ro 31 Gil 19
Guro Gu
Seoul,  KR
Applicant Contact Taehi Chang
Correspondent
Bio-Med USA, Inc.
27 New England Dr.
Ramsey,  NJ  07446
Correspondent Contact Chi Young
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received11/08/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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