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 negative pressure wound therapy powered suction pump
510(k) Number K190119
Device Name Foryou NPWT Dressing Kit
Applicant
4L Health Co., Ltd.
No. 108, Dongxin Rd, DongJiang Hi-tech Dist.
Huizhou,  CN 516000
Applicant Contact Jackie Jian
Correspondent
4L Health Co., Ltd.
No. 108, Dongxin Rd, DongJiang Hi-tech Dist.
Huizhou,  CN 516000
Correspondent Contact Jackie Jian
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/24/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-