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 K132097
Device Name BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
Applicant
Best Medical International, Inc.
7643 Fullerton Rd.
Springfield,  VA  22153
Applicant Contact DHARMENDRA THAKUR
Correspondent
Best Medical International, Inc.
7643 Fullerton Rd.
Springfield,  VA  22153
Correspondent Contact DHARMENDRA THAKUR
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received07/08/2013
Decision Date 09/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-