• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name holder, head, neurosurgical (skull clamp)
510(k) Number K122225
Device Name STERILE RADIOLUCENT SKULL PINS
Original Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen,  DE 85622
Original Contact alexander schwiersch
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/25/2012
Decision Date 04/26/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-