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FDA 510(k)

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE

K-Number: K091762 · 2009-12-22

ApplicantCovidien
Decision Date2009-12-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2009-12-22 under 510(k) number K091762. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE?

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE is a medical device that received FDA 510(k) clearance on 2009-12-22. The listed applicant is Covidien. The 510(k) number is K091762.

When did DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE receive FDA 510(k) clearance?

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE received FDA 510(k) clearance on 2009-12-22, under 510(k) number K091762.

Who is the listed applicant for DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE?

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

What is the FDA product code for DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE?

The FDA product code for DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE is GXY.

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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.

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