• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name source, brachytherapy, radionuclide
510(k) Number K122704
Device Name BEST LOCALIZATION NEEDLE WITH I-125 SEED
Applicant
BEST MEDICAL INTL.
7643 fullerton road
springfield,  VA  22153
Applicant Contact dharmendra thakur
Correspondent
BEST MEDICAL INTL.
7643 fullerton road
springfield,  VA  22153
Correspodent Contact dharmendra thakur
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/04/2012
Decision Date 01/09/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-