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FDA 510(k)

LUHR(R) TITANIUM BURR HOLE COVERS

K-Number: K950115 · 1995-04-10

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

Device Summary

LUHR(R) TITANIUM BURR HOLE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1995-04-10 under 510(k) number K950115. 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 BURR HOLE COVERS?

LUHR(R) TITANIUM BURR HOLE COVERS is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Howmedica, Inc.. The 510(k) number is K950115.

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

LUHR(R) TITANIUM BURR HOLE COVERS received FDA 510(k) clearance on 1995-04-10, under 510(k) number K950115.

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

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

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

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

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Other records listing Howmedica, Inc. as applicant

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Related Devices (Code: 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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