FDA 510(k)

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS

K-Number: K103406 · 2010-12-23

Decision Date2010-12-23

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2010-12-23 under 510(k) number K103406. 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 MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS?

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 2010-12-23. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K103406.

When did MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS receive FDA 510(k) clearance?

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS received FDA 510(k) clearance on 2010-12-23, under 510(k) number K103406.

Who is the listed applicant for MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS?

The FDA product code for MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS 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.