BEUDAMED
    FDA Registration Active 🇺🇸 United States

    bio-ConneKt Wound Matrix

    Reg #: 3009710316 · FEI: 3009710316 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MLM BIOLOGICS
    Registration Number
    3009710316
    FEI Number
    3009710316
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    606 SW 3rd Ave
    City
    Gainesville
    State
    FL
    ZIP
    32601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140456

    Owner / Operator

    Firm Name
    MLM Biologics
    Operator Number
    10047385
    Address
    606 SW 3rd Ave
    City
    Gainesville
    State
    FL
    Postal Code
    32601
    Country
    US
    Correspondent
    Kenneth N Harvey

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN

    Proprietary Names

    bio-ConneKt Wound Matrix OrthoNovis Connect

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device