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FDA 510(k)

HUMAPEN MEMOIR

K-Number: K053563 · 2006-04-07

ApplicantEli Lilly and Company
Decision Date2006-04-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HUMAPEN MEMOIR is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company. It received FDA 510(k) clearance on 2006-04-07 under 510(k) number K053563. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAPEN MEMOIR?

HUMAPEN MEMOIR is a medical device that received FDA 510(k) clearance on 2006-04-07. The listed applicant is Eli Lilly and Company. The 510(k) number is K053563.

When did HUMAPEN MEMOIR receive FDA 510(k) clearance?

HUMAPEN MEMOIR received FDA 510(k) clearance on 2006-04-07, under 510(k) number K053563.

Who is the listed applicant for HUMAPEN MEMOIR?

The FDA 510(k) record lists Eli Lilly and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAPEN MEMOIR?

The FDA product code for HUMAPEN MEMOIR is FMF.

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Other records listing Eli Lilly and Company as applicant

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Related Devices (Code: FMF)

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

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