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FDA 510(k)

DURA MATER

K-Number: K910447 · 1992-06-09

ApplicantLifelink Foundation Tissue Bank
Decision Date1992-06-09
Product CodeLEM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURA MATER is the device name listed in this FDA 510(k) record. The listed applicant is Lifelink Foundation Tissue Bank. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K910447. The device is classified under product code LEM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA MATER?

DURA MATER is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Lifelink Foundation Tissue Bank. The 510(k) number is K910447.

When did DURA MATER receive FDA 510(k) clearance?

DURA MATER received FDA 510(k) clearance on 1992-06-09, under 510(k) number K910447.

Who is the listed applicant for DURA MATER?

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

What is the FDA product code for DURA MATER?

The FDA product code for DURA MATER is LEM.

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Related Devices (Code: LEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910555TUTOPLAST DURAPfrimmer-Viggo GmbH & Co.

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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