BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    InnoSEAL Hemostatic Pad

    Reg #: 3014136088 · FEI: 3014136088 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SCL Science Inc.
    Registration Number
    3014136088
    FEI Number
    3014136088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #1206-1210, ACE hightechcity 2, 25, Seonyu-ro 13-gil, Yeongdeungpo-gu,
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K161013

    Owner / Operator

    Firm Name
    InnoTherapy Inc.
    Operator Number
    10053735
    Address
    #1206-1210, ACE hightechcity 2, 25, Seonyu-ro 13-gil, Yeongdeungpo-gu,
    City
    Seoul
    State
    KR-11
    Postal Code
    07282
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY

    Proprietary Names

    InnoSEAL Hemostatic Pad

    Establishment Types

    Manufacture Medical Device