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FDA 510(k)

GOWN, OPERATING SURGICAL

K-Number: K911568 · 1991-04-22

ApplicantHuntsville Rehabilitation Foundation
Decision Date1991-04-22
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOWN, OPERATING SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Huntsville Rehabilitation Foundation. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K911568. 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 GOWN, OPERATING SURGICAL?

GOWN, OPERATING SURGICAL is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Huntsville Rehabilitation Foundation. The 510(k) number is K911568.

When did GOWN, OPERATING SURGICAL receive FDA 510(k) clearance?

GOWN, OPERATING SURGICAL received FDA 510(k) clearance on 1991-04-22, under 510(k) number K911568.

Who is the listed applicant for GOWN, OPERATING SURGICAL?

The FDA 510(k) record lists Huntsville Rehabilitation Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOWN, OPERATING SURGICAL?

The FDA product code for GOWN, OPERATING SURGICAL is FYA.

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Related Devices (Code: FYA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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