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FDA 510(k)

ELLMAN NOBLE ALLOY ELECTRODES

K-Number: K071343 · 2008-02-28

ApplicantEllman International, Inc.
Decision Date2008-02-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLMAN NOBLE ALLOY ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Ellman International, Inc.. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K071343. 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 ELLMAN NOBLE ALLOY ELECTRODES?

ELLMAN NOBLE ALLOY ELECTRODES is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Ellman International, Inc.. The 510(k) number is K071343.

When did ELLMAN NOBLE ALLOY ELECTRODES receive FDA 510(k) clearance?

ELLMAN NOBLE ALLOY ELECTRODES received FDA 510(k) clearance on 2008-02-28, under 510(k) number K071343.

Who is the listed applicant for ELLMAN NOBLE ALLOY ELECTRODES?

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

What is the FDA product code for ELLMAN NOBLE ALLOY ELECTRODES?

The FDA product code for ELLMAN NOBLE ALLOY ELECTRODES is GEI.

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Official Source

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