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 K984446
Device Name `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
Applicant
Urocor, Inc.
120 NE 26th St.
Oklahoma City,  OK  73105
Applicant Contact STANLEY L MILLS
Correspondent
Urocor, Inc.
120 NE 26th St.
Oklahoma City,  OK  73105
Correspondent Contact STANLEY L MILLS
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/14/1998
Decision Date 04/16/1999
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
-
-