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FDA 510(k)

DISPOSABLE ISOLATION GOWN

K-Number: K911921 · 1991-05-13

ApplicantLiaoning-Usa Corp.
Decision Date1991-05-13
Product CodeFYB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning-Usa Corp.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K911921. The device is classified under product code FYB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ISOLATION GOWN?

DISPOSABLE ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Liaoning-Usa Corp.. The 510(k) number is K911921.

When did DISPOSABLE ISOLATION GOWN receive FDA 510(k) clearance?

DISPOSABLE ISOLATION GOWN received FDA 510(k) clearance on 1991-05-13, under 510(k) number K911921.

Who is the listed applicant for DISPOSABLE ISOLATION GOWN?

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

What is the FDA product code for DISPOSABLE ISOLATION GOWN?

The FDA product code for DISPOSABLE ISOLATION GOWN is FYB.

Related Clinical Trials

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Other records listing Liaoning-Usa Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K905487VARIOUS TYPES OF STETHOSCOPESK910623GAUZE SPONGES ABSORBENT GAUZE ROLLSK902625CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPITK892781ANTELOPE BRAND PATIENT EXAMINATION GLOVESK892774PATIENT EXAMINATION GLOVES

Related Devices (Code: FYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K891820DISPOSABLE MEDICAL GOWNSBioshield, Inc.K891053DENTAL BIBDispomed, Inc.K803171PROCEDURE & RECOVERY PATIENT SUITAlba Health CareK801570SHIELD DISP. PATIENTS PONCHO GOWNSAmerican Convertors Div., American PharmasealK771929PEDIATRICS GOWNConvertors

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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