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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 SOUTH CAMPBELL ST. SUITE #2
VALPARAISO,  IN  46385
Applicant Contact JON D. BARRETT
Correspondent
OMNITECH SYSTEMS, INC.
450 SOUTH 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
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