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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K981464
Device Name OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
Applicant
Omnitech Systems, Inc.
456 S. Cambell, Bldg. C
Valparaiso,  IN  46385
Applicant Contact JON D BARRETT
Correspondent
Omnitech Systems, Inc.
456 S. Cambell, Bldg. C
Valparaiso,  IN  46385
Correspondent Contact JON D BARRETT
Regulation Number884.4160
Classification Product Code
KNF  
Date Received04/23/1998
Decision Date 07/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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