BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURESTEP, LLC

    Reg #: 3003895329 · FEI: 3003895329 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SURESTEP, LLC
    Registration Number
    3003895329
    FEI Number
    3003895329
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17530 DUGDALE DR
    City
    South Bend
    State
    IN
    ZIP
    46635
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203134

    Owner / Operator

    Firm Name
    SURESTEP, LLC
    Operator Number
    10028081
    Address
    17530 DUGDALE DR
    City
    South Bend
    State
    IN
    Postal Code
    46635
    Country
    US
    Correspondent
    SUZI KLIMEK

    Products

    Device Name Product Code
    Orthosis, Cranial MVA
    Orthosis, Cranial, Laser Scan OAN

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device