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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 K203776
Device Name Surgical Masks, Model SNN200640 & MN112
Applicant
Sq Medical Supplies, Inc.
8889 W. Olympic Blvd. Suite 1000 Beverly Hills
Beverly Hills,  CA  90211
Applicant Contact Jonathan Lim
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 703, 705, Bldg. 1, W. Guangzhong Rd. 555,
Shanghai,  CN 200072
Correspondent Contact Shelly Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/28/2020
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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