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FDA 510(k)

Cardinal Health Isolation Gown

K-Number: K160339 · 2016-07-28

ApplicantCardinal Health200, LLC
Decision Date2016-07-28
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Isolation Gown is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2016-07-28 under approval number K160339. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Isolation Gown?

Cardinal Health Isolation Gown is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K160339.

When was Cardinal Health Isolation Gown approved by the FDA?

Cardinal Health Isolation Gown received FDA 510(k) clearance on 2016-07-28, under approval number K160339.

What company makes Cardinal Health Isolation Gown?

Cardinal Health Isolation Gown is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal Health Isolation Gown?

The FDA product code for Cardinal Health Isolation Gown is FYC.

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Other Devices by Cardinal Health200, LLC

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Related Devices (Code: FYC)

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc. K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd. K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC K211538Protect X Level 3 Isolation GownAzac Group

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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