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FDA 510(k)

DISPOSABLE MEDICAL GOWNS

K-Number: K891820 · 1989-07-24

ApplicantBioshield, Inc.
Decision Date1989-07-24
Product CodeFYB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MEDICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Bioshield, Inc.. It received FDA 510(k) clearance on 1989-07-24 under 510(k) number K891820. 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 MEDICAL GOWNS?

DISPOSABLE MEDICAL GOWNS is a medical device that received FDA 510(k) clearance on 1989-07-24. The listed applicant is Bioshield, Inc.. The 510(k) number is K891820.

When did DISPOSABLE MEDICAL GOWNS receive FDA 510(k) clearance?

DISPOSABLE MEDICAL GOWNS received FDA 510(k) clearance on 1989-07-24, under 510(k) number K891820.

Who is the listed applicant for DISPOSABLE MEDICAL GOWNS?

The FDA 510(k) record lists Bioshield, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE MEDICAL GOWNS?

The FDA product code for DISPOSABLE MEDICAL GOWNS is FYB.

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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.

K911921DISPOSABLE ISOLATION GOWNLiaoning-Usa Corp.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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