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FDA 510(k)

LUHR(R) TITANIUM ALLOY BURR HOLE COVERS

K-Number: K950105 · 1995-04-10

ApplicantHowmedica Corp.
Decision Date1995-04-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LUHR(R) TITANIUM ALLOY BURR HOLE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-04-10 under 510(k) number K950105. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUHR(R) TITANIUM ALLOY BURR HOLE COVERS?

LUHR(R) TITANIUM ALLOY BURR HOLE COVERS is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Howmedica Corp.. The 510(k) number is K950105.

When did LUHR(R) TITANIUM ALLOY BURR HOLE COVERS receive FDA 510(k) clearance?

LUHR(R) TITANIUM ALLOY BURR HOLE COVERS received FDA 510(k) clearance on 1995-04-10, under 510(k) number K950105.

Who is the listed applicant for LUHR(R) TITANIUM ALLOY BURR HOLE COVERS?

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

What is the FDA product code for LUHR(R) TITANIUM ALLOY BURR HOLE COVERS?

The FDA product code for LUHR(R) TITANIUM ALLOY BURR HOLE COVERS is HRS.

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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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