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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 K211042
Device Name Disposable Procedural Ear-loop Face Mask
Applicant
Changzhou DSB Medical Co., LTD
No. 98 Fumin Rd, Changzhou Economic Development Zone
Changzhou,  CN 213025
Applicant Contact Sunny Han
Correspondent
Shanghai Sungo Management Consulting Company Limited
13th Floor, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Mandy Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/08/2021
Decision Date 07/15/2021
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
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