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 K210184
Device Name Wilson Tech Disposable Medical Face Mask
Applicant
Wilson Tech (International) Limited
Rm.B, 7 Floor Joy Fat Factory Bldg., 483f&G Castle Peak
Rd.
Kowloon,  HK 999077
Applicant Contact Ho Hang Terry Ting
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. A08, Floor 14th, No 699, Jiaozhou Rd., Jingan District
Shanghai,  CN 200040
Correspondent Contact Julie Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/25/2021
Decision Date 09/14/2021
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
-
-