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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 K981463
Device Name OMNITECH RESECTOSCOPE ROLLER 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 Number884.4160
Classification Product Code
KNF  
Date Received04/23/1998
Decision Date 07/17/1998
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
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