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 K870028
Device Name SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
Applicant
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Applicant Contact COSMAN, PHD
Correspondent
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Correspondent Contact COSMAN, PHD
Regulation Number882.4725
Classification Product Code
GXI  
Date Received01/05/1987
Decision Date 10/26/1987
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
-
-