BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ReShape Calibration Tubes

    Reg #: 3013508647 · FEI: 3013508647 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ReShape Lifesciences
    Registration Number
    3013508647
    FEI Number
    3013508647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7625 Golden Triangle Dr Ste G
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230131

    Owner / Operator

    Firm Name
    ReShape Lifesciences
    Operator Number
    10038397
    Address
    7625 Golden Triangle Drive, Suite G
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Alyssa James

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    ReShape Calibration Tubes

    Establishment Types

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