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 K222266
Device Name Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Applicant
Jingzhou Haixin Green Cross Medical Products Co.,Ltd.
Yongxing North Road No.2 Jingzhou Hubei
Jingzhou,  CN 434007
Applicant Contact Lei Da
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/28/2022
Decision Date 09/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-