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 Electrode, Electrosurgical, Active, Urological
510(k) Number K151976
Device Name Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Applicant
Omnitech Systems, Inc.
450 S. Campbell St. Suite #2
Valparaiso,  IN  46385
Applicant Contact JON D. BARRETT
Correspondent
Omnitech Systems, Inc.
450 S. Campbell St. Suite #2
Valparaiso,  IN  46385
Correspondent Contact JON D. BARRETT
Regulation Number876.4300
Classification Product Code
FAS  
Date Received07/16/2015
Decision Date 06/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-