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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K000032
Device Name LEVEEN NEEDLE ELECTRODE
Applicant
RADIOTHERAPEUTICS CORP.
1308 BORREGAS AVE.SUITE 200
SUNNYVALE,  CA  94089
Applicant Contact GARY CURTIS
Correspondent
RADIOTHERAPEUTICS CORP.
1308 BORREGAS AVE.SUITE 200
SUNNYVALE,  CA  94089
Correspondent Contact GARY CURTIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/05/2000
Decision Date 03/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-