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 Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K945103
Device Name TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact DAVID H MULLER
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact DAVID H MULLER
Regulation Number882.5880
Classification Product Code
GZB  
Date Received10/18/1994
Decision Date 01/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-