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FDA 510(k)

THE Cover

K-Number: K230091 · 2023-10-06

ApplicantPurgo Biologics, Inc.
Decision Date2023-10-06
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE Cover is a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval number K230091. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE Cover?

THE Cover is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K230091.

When was THE Cover approved by the FDA?

THE Cover received FDA 510(k) clearance on 2023-10-06, under approval number K230091.

What company makes THE Cover?

THE Cover is manufactured by Purgo Biologics, Inc..

What is the FDA product code for THE Cover?

The FDA product code for THE Cover is NPL.

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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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