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 K930279
Device Name REFIX(TM) SYSTEM
Applicant
Nomos Corp.
7800 Red Rd.
Suite 330-D
South Miami,  FL  33143
Applicant Contact HARRIS TARGOVNIK
Correspondent
Nomos Corp.
7800 Red Rd.
Suite 330-D
South Miami,  FL  33143
Correspondent Contact HARRIS TARGOVNIK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/21/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-