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FDA 510(k)

LAC-MAC INNERBLOC O.R. GOWN

K-Number: K061491 · 2006-08-09

ApplicantLac Mac, Ltd.
Decision Date2006-08-09
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAC-MAC INNERBLOC O.R. GOWN 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 2006-08-09 under 510(k) number K061491. 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 LAC-MAC INNERBLOC O.R. GOWN?

LAC-MAC INNERBLOC O.R. GOWN is a medical device that received FDA 510(k) clearance on 2006-08-09. The listed applicant is Lac Mac, Ltd.. The 510(k) number is K061491.

When did LAC-MAC INNERBLOC O.R. GOWN receive FDA 510(k) clearance?

LAC-MAC INNERBLOC O.R. GOWN received FDA 510(k) clearance on 2006-08-09, under 510(k) number K061491.

Who is the listed applicant for LAC-MAC INNERBLOC O.R. GOWN?

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 LAC-MAC INNERBLOC O.R. GOWN?

The FDA product code for LAC-MAC INNERBLOC O.R. GOWN is FYA.

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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 GOWNSK032631INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)K031362LAC-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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