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FDA 510(k)

STIMULATING BUR GUARD

K-Number: K063305 · 2006-11-29

ApplicantMedtronic Xomed, Inc.
Decision Date2006-11-29
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STIMULATING BUR GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2006-11-29 under 510(k) number K063305. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMULATING BUR GUARD?

STIMULATING BUR GUARD is a medical device that received FDA 510(k) clearance on 2006-11-29. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K063305.

When did STIMULATING BUR GUARD receive FDA 510(k) clearance?

STIMULATING BUR GUARD received FDA 510(k) clearance on 2006-11-29, under 510(k) number K063305.

Who is the listed applicant for STIMULATING BUR GUARD?

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

What is the FDA product code for STIMULATING BUR GUARD?

The FDA product code for STIMULATING BUR GUARD is ETN.

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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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