BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BlueSkyBio

    Reg #: 3007366413 · FEI: 3007366413 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    F. M. HOWELL & CO.
    Registration Number
    3007366413
    FEI Number
    3007366413
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 E. MILLER ST., P. O. BOX 286
    City
    Elmira
    State
    NY
    ZIP
    14902
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060957

    Owner / Operator

    Firm Name
    F.M. HOWELL & CO.
    Operator Number
    1313700
    Address
    151 EAST FIFTH ST., P.O. BOX 286
    City
    Elmira
    State
    NY
    Postal Code
    14902
    Country
    US
    Correspondent
    KATHERINE H ROEHLKE

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    BlueSkyBio

    Establishment Types

    Repack or Relabel Medical Device