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 K892884
Device Name MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact LINDA S ALEXANDER
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact LINDA S ALEXANDER
Regulation Number882.5880
Classification Product Code
GZB  
Date Received04/19/1989
Decision Date 08/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-