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FDA 510(k)

Medline Prevention CoolZone Gown

K-Number: K172954 · 2018-06-15

ApplicantMedline Industries, Inc.
Decision Date2018-06-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Prevention CoolZone Gown is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-06-15 under approval number K172954. 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 Prevention CoolZone Gown?

Medline Prevention CoolZone Gown is a medical device that received FDA 510(k) clearance on 2018-06-15. It is manufactured by Medline Industries, Inc.. The 510(k) number is K172954.

When was Medline Prevention CoolZone Gown approved by the FDA?

Medline Prevention CoolZone Gown received FDA 510(k) clearance on 2018-06-15, under approval number K172954.

What company makes Medline Prevention CoolZone Gown?

Medline Prevention CoolZone Gown is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Prevention CoolZone Gown?

The FDA product code for Medline Prevention CoolZone 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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