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 Stopcock, I.V. Set
510(k) Number K954970
Device Name STOPCOCK & LUER LOCK PLUG
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Applicant Contact JOHN C TOOMEY
Correspondent
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Correspondent Contact JOHN C TOOMEY
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/30/1995
Decision Date 04/22/1996
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
Recalls CDRH Recalls
-
-