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, Antistick
510(k) Number K141464
Device Name NOVAGUARD S A SAFETY SYSTEM
Applicant
West Pharmaceutical Services
530 Herman O. W. Dr.
Exton,  PA  19341 -1147
Applicant Contact KEVIN LENTZ
Correspondent
West Pharmaceutical Services
530 Herman O. W. Dr.
Exton,  PA  19341 -1147
Correspondent Contact KEVIN LENTZ
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/03/2014
Decision Date 09/10/2014
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
-
-