FDA 510(k)

PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A

K-Number: K080627 · 2008-04-24

Decision Date2008-04-24

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A 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 2008-04-24 under 510(k) number K080627. 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 GOWNS, MODELS: 1002494A, 100770A?

PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A is a medical device that received FDA 510(k) clearance on 2008-04-24. The listed applicant is Promedical Products Co., Ltd.. The 510(k) number is K080627.

When did PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A receive FDA 510(k) clearance?

PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A received FDA 510(k) clearance on 2008-04-24, under 510(k) number K080627.

Who is the listed applicant for PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A?

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 GOWNS, MODELS: 1002494A, 100770A?

The FDA product code for PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A is FYA.

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Other records listing Promedical Products Co., Ltd. as applicant

K091097PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 K080629PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS K042111PROMEDICAL SURGICAL GOWNS K042131PROMEDICAL SURGICAL DRAPES K042137PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

Related Devices (Code: FYA)

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 Studio K252575Tuff 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.