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 system, applicator, radionuclide, remote-controlled
510(k) Number K061241
Device Name BIOLUCENT APPLICATOR, MODEL RTA-XX
Applicant
BIOLUCENT, INC.
6 JOURNEY, SUITE 325
aliso viejo,  CA  92656
Applicant Contact j. david campbell
Correspondent
BIOLUCENT, INC.
6 JOURNEY, SUITE 325
aliso viejo,  CA  92656
Correspondent Contact j. david campbell
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received05/03/2006
Decision Date 07/28/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-