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 Building,No.64,
Xin’an 2nd Road, Baoan District
Shenzhen,  CN
Applicant Contact Tang Renxian
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th F, 1500# Century Avenue
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
-
-