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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 K965093
Device Name OMNITECH RESECTOSCOPE ROLLER ELECTRODE
Applicant
OMNITECH SYSTEMS, INC.
456 SOUTH CAMBELL, BLDG. C
VALPARAISO,  IN  46385
Applicant Contact GENE S ESTILL
Correspondent
OMNITECH SYSTEMS, INC.
456 SOUTH CAMBELL, BLDG. C
VALPARAISO,  IN  46385
Correspondent Contact GENE S ESTILL
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
FDC  
Date Received12/19/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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