• 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 clip, aneurysm
510(k) Number K180757
Device Name D-Clip; D-Clip Applier
Peter Lazic GmbH
Immelmannweg 2
Tuttlingen,  DE 78532
Applicant Contact Sven Lazic
Peter Lazic GmbH
Immelmannweg 2
Tuttlingen,  DE 78532
Correspondent Contact Sven Lazic
Regulation Number882.5200
Classification Product Code
Subsequent Product Code
Date Received03/22/2018
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No