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FDA 510(k)

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

K-Number: K091097 · 2009-05-27

ApplicantPromedical Products Co., Ltd.
Decision Date2009-05-27
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 is the device name listed in this FDA 510(k) record. The listed applicant is Promedical Products Co., Ltd.. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K091097. 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 PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501?

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Promedical Products Co., Ltd.. The 510(k) number is K091097.

When did PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 receive FDA 510(k) clearance?

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 received FDA 510(k) clearance on 2009-05-27, under 510(k) number K091097.

Who is the listed applicant for PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501?

The FDA 510(k) record lists Promedical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501?

The FDA product code for PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 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 Promedical Products Co., Ltd. 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.

K080629PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGSK080627PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770AK042111PROMEDICAL SURGICAL GOWNSK042131PROMEDICAL SURGICAL DRAPESK042137PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

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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