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 accelerator, linear, medical
510(k) Number K023636
Device Name BLOCKING TRAY
Applicant
SOUTHEASTERN RADIATION PRODUCTS, INC.
2651 N. DESIGN COURT
SANFORD,  FL  32773
Applicant Contact RICHARD SWEAT
Correspondent
SOUTHEASTERN RADIATION PRODUCTS, INC.
2651 N. DESIGN COURT
SANFORD,  FL  32773
Correspondent Contact RICHARD SWEAT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/30/2002
Decision Date 11/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-