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 K222697
Device Name Disposable Medical Face Mask (DF3-001)
Applicant
Wellmed Dental Medical Supply Co., Ltd.
301 Zhongxing Science And Technology Bldg.,#64,
Xin’An 2nd Rd., Baoan District
Shenzhen,  CN
Applicant Contact Tang Renxian
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th F 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/07/2022
Decision Date 11/04/2022
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
-
-