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FDA 510(k)

OSFERION

K-Number: K080065 · 2008-05-02

ApplicantOlympus Terumo Biomaterials Corporation
Decision Date2008-05-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSFERION 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 2008-05-02 under 510(k) number K080065. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSFERION?

OSFERION is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Olympus Terumo Biomaterials Corporation. The 510(k) number is K080065.

When did OSFERION receive FDA 510(k) clearance?

OSFERION received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080065.

Who is the listed applicant for OSFERION?

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?

The FDA product code for OSFERION is MQV.

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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.

K111087FOUNDATIONK081561OSFERION D

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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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