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 K073107
Device Name VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
Applicant
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Applicant Contact LISA] DIMMICK
Correspondent
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Correspondent Contact LISA] DIMMICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received11/02/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-