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FDA 510(k)

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*

K-Number: K902348 · 1990-09-06

ApplicantFuturistic Medical Concepts, Inc.
Decision Date1990-09-06
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* is the device name listed in this FDA 510(k) record. The listed applicant is Futuristic Medical Concepts, Inc.. It received FDA 510(k) clearance on 1990-09-06 under 510(k) number K902348. 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 SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*?

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* is a medical device that received FDA 510(k) clearance on 1990-09-06. The listed applicant is Futuristic Medical Concepts, Inc.. The 510(k) number is K902348.

When did SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* receive FDA 510(k) clearance?

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* received FDA 510(k) clearance on 1990-09-06, under 510(k) number K902348.

Who is the listed applicant for SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*?

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

What is the FDA product code for SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*?

The FDA product code for SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* is FYA.

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

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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