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FDA 510(k)

FOUNDATION

K-Number: K111087 · 2011-11-29

ApplicantOlympus Terumo Biomaterials Corporation
Decision Date2011-11-29
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOUNDATION 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 2011-11-29 under 510(k) number K111087. 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 FOUNDATION?

FOUNDATION is a medical device that received FDA 510(k) clearance on 2011-11-29. The listed applicant is Olympus Terumo Biomaterials Corporation. The 510(k) number is K111087.

When did FOUNDATION receive FDA 510(k) clearance?

FOUNDATION received FDA 510(k) clearance on 2011-11-29, under 510(k) number K111087.

Who is the listed applicant for FOUNDATION?

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 FOUNDATION?

The FDA product code for FOUNDATION is LYC.

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Related PubMed Literature

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.

PMID: 34478784Foundational Considerations for Artificial Intelligence Using Ophthalmic Images.Ophthalmology ()

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.

K081561OSFERION DK080065OSFERION

Related Devices (Code: LYC)

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.

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Official Source

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