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FDA 510(k)

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE

K-Number: K012240 · 2001-10-15

ApplicantMercan AB
Decision Date2001-10-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE is the device name listed in this FDA 510(k) record. The listed applicant is Mercan AB. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K012240. 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 MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE?

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Mercan AB. The 510(k) number is K012240.

When did MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE receive FDA 510(k) clearance?

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012240.

Who is the listed applicant for MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE?

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

What is the FDA product code for MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE?

The FDA product code for MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE is FYA.

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Other records listing Mercan AB 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.

K012237MERTEX-PLUS REUSABLE SURGICAL DRAPE

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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