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FDA 510(k)

OSFERION D

K-Number: K081561 · 2008-07-28

ApplicantOlympus Terumo Biomaterials Corporation
Decision Date2008-07-28
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSFERION D is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Terumo Biomaterials Corporation. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K081561. 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 OSFERION D?

OSFERION D is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Olympus Terumo Biomaterials Corporation. The 510(k) number is K081561.

When did OSFERION D receive FDA 510(k) clearance?

OSFERION D received FDA 510(k) clearance on 2008-07-28, under 510(k) number K081561.

Who is the listed applicant for OSFERION D?

The FDA 510(k) record lists Olympus Terumo Biomaterials Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSFERION D?

The FDA product code for OSFERION D is LYC.

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Other records listing Olympus Terumo Biomaterials Corporation as applicant

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.

K111087FOUNDATIONK080065OSFERION

Related Devices (Code: LYC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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