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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K211105
Device Name Ear-Friendly Mask
Applicant
Ray Co., Ltd.
38, Simin-Daero, Manan-Gu
Anyang-Si,  KR 14098
Applicant Contact Changhwan Lee
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/13/2021
Decision Date 05/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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