BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LevaLap

    Reg #: 3026197439 · FEI: 3026197439 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CORE ACCESS SURGICAL TECHNOLOGIES, INC.
    Registration Number
    3026197439
    FEI Number
    3026197439
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3495 Piedmont Rd NE, Building 11, Suite 905
    City
    Atlanta
    State
    GA
    ZIP
    30305
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212786

    Owner / Operator

    Firm Name
    CORE ACCESS SURGICAL TECHNOLOGIES, INC.
    Operator Number
    10087237
    Address
    3495 Piedmont Rd NE, Building 11, Suite 905
    City
    Atlanta
    State
    GA
    Postal Code
    30305
    Country
    US

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF

    Proprietary Names

    LevaLap

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility