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 K011255
Device Name 3D LINE STEROTACTIC HARDWARE ACCESSORIES
Applicant
3D LINE USA, INC.
2807 OLD COURT RD.
BALTIMORE,  MD  21208
Applicant Contact KAREN H RIGAMONTI
Correspondent
3D LINE USA, INC.
2807 OLD COURT RD.
BALTIMORE,  MD  21208
Correspondent Contact KAREN H RIGAMONTI
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYE  
Date Received04/24/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-