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 K162573
Device Name Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
Applicant
Source Production and Equipment Co., Inc.
113 Teal St.
Saint Rose,  LA  70087
Applicant Contact KELLEY RICHARDT
Correspondent
Source Production and Equipment Co., Inc.
113 Teal St.
Saint Rose,  LA  70087
Correspondent Contact KELLEY RICHARDT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/15/2016
Decision Date 11/04/2016
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
-
-