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 Dressing, Wound, Drug
510(k) Number K210466
Device Name Silver Gelling Fiber Dressing
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, # 660 Bulong Rd., Longhua
District
Shenzhen,  CN 51809
Applicant Contact Haoyuan He
Correspondent
Winner Medical Co., Ltd.
Winner Industrial Park, # 660 Bulong Rd., Longhua
District
Shenzhen,  CN 51809
Correspondent Contact Haoyuan He
Classification Product Code
FRO  
Date Received02/16/2021
Decision Date 01/14/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-