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 Needle, Hypodermic, Single Lumen
510(k) Number K181508
Device Name U&U Blood Collection Sets
Applicant
U&U Medical Technology Co, Ltd.
Dongzhou Village
Hengshanqiao
Changzhou,  CN 213119
Applicant Contact Nick Wang
Correspondent
U&U Medical Technology Co, Ltd.
Dongzhou Village
Hengshanqiao
Changzhou,  CN 213119
Correspondent Contact Nick Wang
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
JKA  
Date Received06/07/2018
Decision Date 02/13/2019
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
Predetermined Change
Control Plan Authorized		 No
-
-