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 K150562
Device Name Safe'n'Sound Staked Passive Delivery System - Plajex version
Applicant
Nemera
600 Deerfield Pkwy.
Buffalo Grove,  IL  60089
Applicant Contact James A WERKAMP
Correspondent
Nemera
20 Ave. De La Gare
La Verpilliere,  FR 38292
Correspondent Contact Beatrice GRAND DEMARS
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/06/2015
Decision Date 06/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-