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FDA 510(k)

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

K-Number: K202310 · 2021-01-29

ApplicantWildcat Ppe, LLC
Decision Date2021-01-29
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is a medical device manufactured by Wildcat Ppe, LLC. It received FDA 510(k) clearance on 2021-01-29 under approval number K202310. 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 Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Wildcat Ppe, LLC. The 510(k) number is K202310.

When was Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back approved by the FDA?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back received FDA 510(k) clearance on 2021-01-29, under approval number K202310.

What company makes Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is manufactured by Wildcat Ppe, LLC.

What is the FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

The FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is FYC.

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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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