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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 K202133
Device Name Disposable Medical Mask
Applicant
Hangzhou Qianzhiya Sanitary Products Co., Ltd.
#88 Fengwang Rd., Economic Development Zone Tonglu,
Tonglu County
Hangzhou,  CN 311500
Applicant Contact Yu Shao
Correspondent
Shanghai Sungo Management Consulting Company Limited.
13th Floor, 1500# Central Ave.
Shangghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/31/2020
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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