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FDA 510(k)

BONEMEDIK-DM

K-Number: K080772 · 2008-06-03

ApplicantMeta Biomed Co., Ltd.
Decision Date2008-06-03
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONEMEDIK-DM is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2008-06-03 under 510(k) number K080772. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONEMEDIK-DM?

BONEMEDIK-DM is a medical device that received FDA 510(k) clearance on 2008-06-03. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K080772.

When did BONEMEDIK-DM receive FDA 510(k) clearance?

BONEMEDIK-DM received FDA 510(k) clearance on 2008-06-03, under 510(k) number K080772.

Who is the listed applicant for BONEMEDIK-DM?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONEMEDIK-DM?

The FDA product code for BONEMEDIK-DM is LYC.

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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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