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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 K202211
Device Name Disposable Medical Surgical Face Masks
Applicant
Guangdong Kaidi Garments Co.,Ltd
Shenxiyang Industrial Zone, Fengshan St., Heping Town
Shantou,  CN 515000
Applicant Contact MR./MRS. Vicky
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 Received08/06/2020
Decision Date 12/22/2020
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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