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 neurological stereotaxic instrument
510(k) Number K152558
Device Name Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18, P.O. BOX 7593
STOCKHOLM,  SE SE-103 93
Applicant Contact EMMA WIDMARK
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18, P.O. BOX 7593
STOCKHOLM,  SE SE-103 93
Correspondent Contact EMMA WIDMARK
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/09/2015
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-