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FDA 510(k)

SRI LEVEL II SURGICAL GOWN

K-Number: K090383 · 2009-05-29

ApplicantSri Surgical
Decision Date2009-05-29
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SRI LEVEL II SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Sri Surgical. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K090383. 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 LEVEL II SURGICAL GOWN?

SRI LEVEL II SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Sri Surgical. The 510(k) number is K090383.

When did SRI LEVEL II SURGICAL GOWN receive FDA 510(k) clearance?

SRI LEVEL II SURGICAL GOWN received FDA 510(k) clearance on 2009-05-29, under 510(k) number K090383.

Who is the listed applicant for SRI LEVEL II SURGICAL GOWN?

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

What is the FDA product code for SRI LEVEL II SURGICAL GOWN?

The FDA product code for SRI LEVEL II SURGICAL GOWN 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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