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FDA 510(k)

Cellusheet, Cellufil

K-Number: K213092 · 2021-12-15

ApplicantHuman Biosciences, Inc.
Decision Date2021-12-15
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Cellusheet, Cellufil is a medical device manufactured by Human Biosciences, Inc.. It received FDA 510(k) clearance on 2021-12-15 under approval number K213092. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellusheet, Cellufil?

Cellusheet, Cellufil is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Human Biosciences, Inc.. The 510(k) number is K213092.

When was Cellusheet, Cellufil approved by the FDA?

Cellusheet, Cellufil received FDA 510(k) clearance on 2021-12-15, under approval number K213092.

What company makes Cellusheet, Cellufil?

Cellusheet, Cellufil is manufactured by Human Biosciences, Inc..

What is the FDA product code for Cellusheet, Cellufil?

The FDA product code for Cellusheet, Cellufil is KGN.

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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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