BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pocket Colposcope

    Reg #: 3016965604 · FEI: 3016965604 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CALLA HEALTH FOUNDATION
    Registration Number
    3016965604
    FEI Number
    3016965604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    701 W Main St Ste 200
    City
    Durham
    State
    NC
    ZIP
    27701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181034

    Owner / Operator

    Firm Name
    Calla Health Foundation
    Operator Number
    10075188
    Address
    701 W. Main Street, Suite 200
    City
    Durham
    State
    NC
    Postal Code
    27701
    Country
    US
    Correspondent
    Marlee Krieger

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    Pocket Colposcope

    Establishment Types

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