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 K250082
Device Name Procedure mask/Surgical mask/Face mask
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua District
42nd Floor Bldg. No 2, Huilong Business Center
Shenzhen,  CN 518109
Applicant Contact Jiali Liu
Correspondent
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua District
42nd Floor Bldg. No 2, Huilong Business Center
Shenzhen,  CN 518109
Correspondent Contact Jiali Liu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/13/2025
Decision Date 06/18/2025
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
-
-