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FDA 510(k)

InnoGenic Non-resorbable Membrane

K-Number: K211554 · 2023-02-24

ApplicantCowellmedi Co., Ltd.
Decision Date2023-02-24
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InnoGenic Non-resorbable Membrane is a medical device manufactured by Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under approval number K211554. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InnoGenic Non-resorbable Membrane?

InnoGenic Non-resorbable Membrane is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Cowellmedi Co., Ltd.. The 510(k) number is K211554.

When was InnoGenic Non-resorbable Membrane approved by the FDA?

InnoGenic Non-resorbable Membrane received FDA 510(k) clearance on 2023-02-24, under approval number K211554.

What company makes InnoGenic Non-resorbable Membrane?

InnoGenic Non-resorbable Membrane is manufactured by Cowellmedi Co., Ltd..

What is the FDA product code for InnoGenic Non-resorbable Membrane?

The FDA product code for InnoGenic Non-resorbable Membrane is NPK.

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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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