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, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K190026
Device Name Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
Applicant
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Lakshmi Kanuri
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Lakshmi Kanuri
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/07/2019
Decision Date 08/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-