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 K152339
Device Name Unifine Pentips/ Unifine Pentips Plus
Applicant
OWEN MUMFORD LTD
BROOK HILL
WOODSTOCK,  GB OX20 ITU
Applicant Contact Patty Cronan
Correspondent
OWEN MUMFORD USA, INC.
1755 WEST OAK COMMONS CT.
MARIETTA,  GA  30062
Correspondent Contact Patty Cronan
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/19/2015
Decision Date 06/24/2016
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
Recalls CDRH Recalls
-
-