OMNITECH RESECTOSCOPE ROLLER ELECTRODE

Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

OMNITECH SYSTEMS, INC.

The following data is part of a premarket notification filed by Omnitech Systems, Inc. with the FDA for Omnitech Resectoscope Roller Electrode.

Pre-market Notification Details

Device IDK981463
510k NumberK981463
Device Name:OMNITECH RESECTOSCOPE ROLLER ELECTRODE
ClassificationCoagulator-cutter, Endoscopic, Unipolar (and Accessories)
Applicant OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C Valparaiso,  IN  46385
ContactJon D Barrett
CorrespondentJon D Barrett
OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C Valparaiso,  IN  46385
Product CodeKNF  
CFR Regulation Number884.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-23
Decision Date1998-07-17

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