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FDA 510(k)

Medline Orbis Surgical Gown

K-Number: K202447 · 2021-04-02

ApplicantMedline Industries, Inc.
Decision Date2021-04-02
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Orbis Surgical Gown is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-04-02 under approval number K202447. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Orbis Surgical Gown?

Medline Orbis Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-04-02. It is manufactured by Medline Industries, Inc.. The 510(k) number is K202447.

When was Medline Orbis Surgical Gown approved by the FDA?

Medline Orbis Surgical Gown received FDA 510(k) clearance on 2021-04-02, under approval number K202447.

What company makes Medline Orbis Surgical Gown?

Medline Orbis Surgical Gown is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Orbis Surgical Gown?

The FDA product code for Medline Orbis Surgical Gown is FYA.

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Related Devices (Code: FYA)

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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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