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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 K201691
Device Name Single-Use Surgical Mask With Ear Loop
Applicant
Qiqihar Hengxin Medical Supplies, Ltd.
10th Beijiang Rd. In Tiefeng Industrial Park,
North Shuguang Ave. Tiefeng District
Qiqihar,  CN 161000
Applicant Contact Sihui Xiong
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/22/2020
Decision Date 09/17/2020
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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