Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mask, surgical
510(k) Number K201991
Device Name Medical surgical mask
Applicant
Shenzhen Everwin Precision Technology Co., Ltd.
Block A&B&C, NCBC Industrial Park, 6th Baolong Road,
Longgang District
Shenzhen,  CN 518103
Applicant Contact Guoshun Shi
Correspondent
Guangzhou Osmunda Medical Device Technical Services Co.,Ltd.
8-9th Floor, R&D Building, No.26 Qinglan Street,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/17/2020
Decision Date 11/23/2020
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
-
-