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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K211139
Device Name CUBE Air Purifier
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Hana Jung
Correspondent
Mdlab, Inc.
# Rm. 804, 161-17, Magokjungang-Ro, Gangseo-Gu,
Seoul,  KR 07788
Correspondent Contact Kyoungju Kim
Regulation Number880.6500
Classification Product Code
FRA  
Date Received04/16/2021
Decision Date 11/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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