FDA 510(k)

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400

K-Number: K091357 · 2009-08-10

Decision Date2009-08-10

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 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 2009-08-10 under 510(k) number K091357. 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 SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400?

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 is a medical device that received FDA 510(k) clearance on 2009-08-10. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K091357.

When did MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 receive FDA 510(k) clearance?

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 received FDA 510(k) clearance on 2009-08-10, under 510(k) number K091357.

Who is the listed applicant for MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400?

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 SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400?

The FDA product code for MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 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.