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FDA 510(k)

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)

K-Number: K032631 · 2004-02-05

ApplicantLac Mac, Ltd.
Decision Date2004-02-05
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) is the device name listed in this FDA 510(k) record. The listed applicant is Lac Mac, Ltd.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K032631. 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 INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)?

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is Lac Mac, Ltd.. The 510(k) number is K032631.

When did INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) receive FDA 510(k) clearance?

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) received FDA 510(k) clearance on 2004-02-05, under 510(k) number K032631.

Who is the listed applicant for INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)?

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

What is the FDA product code for INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)?

The FDA product code for INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) 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 Lac Mac, 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.

K10286484E SERIES SINGLE PLY WRAPPERK092344LAC-MAC INNERBLOC LR SURGICAL GOWNSK061491LAC-MAC INNERBLOC O.R. GOWNK031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSK030536LAC-MAC LIMITED INNERBLOC O.R. 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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