BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter

    Reg #: 3012167431 · FEI: 3012167431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MERIL INC
    Registration Number
    3012167431
    FEI Number
    3012167431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2436 Emrick Boulevard
    City
    Bethlehem
    State
    PA
    ZIP
    18020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160961

    Owner / Operator

    Firm Name
    Meril Inc
    Operator Number
    10049695
    Address
    2436 Emrick Boulevard
    City
    Bethlehem
    State
    PA
    Postal Code
    18020
    Country
    US
    Correspondent
    Kaiyumkhan Patel

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198