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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 K050454
Device Name OMNITECH FULGURATING ELECTRODE
Applicant
OMNITECH SYSTEMS, INC.
456 SOUTH CAMBELL, BLDG. C
VALPARAISO,  IN  46385
Applicant Contact JON D BARRETT
Correspondent
OMNITECH SYSTEMS, INC.
456 SOUTH CAMBELL, BLDG. C
VALPARAISO,  IN  46385
Correspondent Contact JON D BARRETT
Regulation Number876.4300
Classification Product Code
FAS  
Date Received02/22/2005
Decision Date 05/27/2005
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
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