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 mediastinoscope, surgical
510(k) Number K141622
Device Name ILLUMINATED MEDIASTINOSCOPE
Applicant
AEGIS SURGICAL LTD
113 GRANTWOOD DRIVE
HOLLY SPRINGS,  NC  27540
Applicant Contact TAMMY CARREA
Correspondent
AEGIS SURGICAL LTD
113 GRANTWOOD DRIVE
HOLLY SPRINGS,  NC  27540
Correspondent Contact TAMMY CARREA
Regulation Number874.4720
Classification Product Code
EWY  
Date Received06/17/2014
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-