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 K142719
Device Name E-App
Applicant
Gc Medtech, LLC
490 W. 84th St.
Hialeah,  FL  33014
Applicant Contact Robert Ramirez
Correspondent
Regulatory Strategies, Inc.
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Correspondent Contact Gregory Mathison
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/23/2014
Decision Date 05/20/2015
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
-
-