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 K210744
Device Name Surgical Mask
Applicant
Chongqing Pa Xijia Biotechnology Co., Ltd.
No. 27-5, Fengsheng Road, Jiulongpo District
Chongqing,  CN 400053
Applicant Contact Zheng Tao
Correspondent
Sichuan JIULUEHUI Consulting Co., Ltd.
Room 1401, Building 4, No. 666, Chenglong Avenue
Chengdu,  CN 610101
Correspondent Contact May Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/12/2021
Decision Date 12/14/2021
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
-
-