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 Probe, Radiofrequency Lesion
510(k) Number K021942
Device Name RADIONICS POLE NEEDLES
Applicant
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received06/13/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-