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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 K964365
Device Name RESECTOSCOPE CUTTING LOOP ELECTRODE
Applicant
Omnitech Systems, Inc.
456 S. Cambell, Bldg. C
Valparaiso,  IN  46385
Applicant Contact GENE S ESTILL
Correspondent
Omnitech Systems, Inc.
456 S. Cambell, Bldg. C
Valparaiso,  IN  46385
Correspondent Contact GENE S ESTILL
Regulation Number876.4300
Classification Product Code
FAS  
Date Received11/01/1996
Decision Date 04/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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