BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPIRAIR, INC

    Reg #: 3030653921 · FEI: 3030653921 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    SPIRAIR, INC
    Registration Number
    3030653921
    FEI Number
    3030653921
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    415 Grand Avenue, Suite 201
    City
    South San Francisco
    State
    CA
    ZIP
    94080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243655

    Owner / Operator

    Firm Name
    Spirair, Inc
    Operator Number
    10090843
    Address
    415 Grand Avenue, Suite 201
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US
    Correspondent
    Tracey Henry

    Products

    Device Name Product Code
    Splint, Intranasal Septal LYA
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB

    Proprietary Names

    TurbAlign SeptAlign

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device