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 Rongeur, Manual
510(k) Number K150468
Device Name Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
Applicant
K2 Medical GmbH & Co. KG
Unter Buchsteig 5
Tuttlingen,  DE
Applicant Contact Harald Jung
Correspondent
K2 Medical GmbH & Co. KG
Unter Buchsteig 5
Tuttlingen,  DE
Correspondent Contact Harald Jung
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/23/2015
Decision Date 02/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-