BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vocom Vocal Cord Medial Shim

    Reg #: 1037007 · FEI: 1037007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GYRUS ACMI, INC.
    Registration Number
    1037007
    FEI Number
    1037007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2925 Appling Rd
    City
    BARTLETT
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974311

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ

    Proprietary Names

    Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device