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 Source, Brachytherapy, Radionuclide
510(k) Number K030534
Device Name VARISEED 7.1
Applicant
VARIAN MEDICAL SYSTEMS
700 HARRIS STREET
SUITE 109
CHARLOTTESVILLE,  VA  22903 -1038
Applicant Contact LINDA S NASH
Correspondent
VARIAN MEDICAL SYSTEMS
700 HARRIS STREET
SUITE 109
CHARLOTTESVILLE,  VA  22903 -1038
Correspondent Contact LINDA S NASH
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/20/2003
Decision Date 05/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-