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 Gown, Surgical
510(k) Number K213703
Device Name Surgical Gown
Applicant
Wujiang Tutaike Textiles & Finishing Co., Ltd.
#1599, S. 3rd Ring Rd., Shengze, Wujiang
Suzhou,  CN 317605
Applicant Contact Zhang Yanwen
Correspondent
Shanghai Mil-Medshare Medical Technology Co., Ltd.
Shandong,  CN
Correspondent Contact Kevin Chen
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/24/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-