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FDA 510(k)

SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN

K-Number: K023635 · 2002-11-18

ApplicantSri/Surgical Express, Inc.
Decision Date2002-11-18
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Sri/Surgical Express, Inc.. It received FDA 510(k) clearance on 2002-11-18 under 510(k) number K023635. 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 SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN?

SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 2002-11-18. The listed applicant is Sri/Surgical Express, Inc.. The 510(k) number is K023635.

When did SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN receive FDA 510(k) clearance?

SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN received FDA 510(k) clearance on 2002-11-18, under 510(k) number K023635.

Who is the listed applicant for SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN?

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

What is the FDA product code for SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN?

The FDA product code for SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN is FYA.

Related Clinical Trials

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.

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Other records listing Sri/Surgical Express, Inc. 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.

K080723SRI LP GOWN

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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