OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE— 510(k) K981464

Name: FDA 510(k) clearance K981464
Creator: U.S. Food and Drug Administration
Published: 1998-07-10

Substantially Equivalent

Omnitech Systems, Inc.

FDA 510(k) clearance K981464 for OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE, Substantially Equivalent on 1998-07-10. Applicant: Omnitech Systems, Inc.. Device class: 2.

Clearance details

Applicant: Omnitech Systems, Inc.
Product code: Code KNF
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 1998-04-23
Decision date: 1998-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valparaiso, IN, US

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