FDA 510(k)

TEFLON COATED ELECTRODES/ELECTRODES HANDLES

K-Number: K913108 · 1991-12-23

Decision Date1991-12-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TEFLON COATED ELECTRODES/ELECTRODES HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Electrosurgical, Inc.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K913108. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEFLON COATED ELECTRODES/ELECTRODES HANDLES?

TEFLON COATED ELECTRODES/ELECTRODES HANDLES is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Olsen Electrosurgical, Inc.. The 510(k) number is K913108.

When did TEFLON COATED ELECTRODES/ELECTRODES HANDLES receive FDA 510(k) clearance?

TEFLON COATED ELECTRODES/ELECTRODES HANDLES received FDA 510(k) clearance on 1991-12-23, under 510(k) number K913108.

Who is the listed applicant for TEFLON COATED ELECTRODES/ELECTRODES HANDLES?

The FDA 510(k) record lists Olsen Electrosurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEFLON COATED ELECTRODES/ELECTRODES HANDLES?

The FDA product code for TEFLON COATED ELECTRODES/ELECTRODES HANDLES is GEI.

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Other records listing Olsen Electrosurgical, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.