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 Drills, Burrs, Trephines & Accessories (Compound, Powered)
510(k) Number K213228
Device Name NeuroLine Disposable Cranial Perforator with Hudson end
Applicant
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Bartok Bela U. 113/B
Debrecen,  HU 4031
Applicant Contact Gyula Ujvari
Correspondent
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Bartok Bela U. 113/B
Debrecen,  HU 4031
Correspondent Contact Gergo Ujvari
Regulation Number882.4305
Classification Product Code
HBF  
Date Received09/29/2021
Decision Date 06/20/2022
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
-
-