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 syringe, piston
510(k) Number K163161
Device Name Sterile Single-use Syringe with Needle
Applicant
JiangXi HongDa Medical Equipment Group Ltd.
No. 39 South Shengli Road, Jinxian County
Nanchang,  CN 331700
Applicant Contact Yang Xiaohua
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119,
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received11/10/2016
Decision Date 03/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-