BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LOSEFF BALLOON TYPE SELF-RETENTION WOUND

    K Number: K801349 · Decision Aug 7, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    59

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LOSEFF BALLOON TYPE SELF-RETENTION WOUND
    K Number
    K801349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Loseff Medical Designers, Ltd.
    Date Received
    June 9, 1980
    Decision Date
    August 7, 1980
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JCX), ordered by most recent decision date.

    Protable Phlegm Suction Unit (JMA D01)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MV Flow Aspiration Pump (MVFLOWPMP01)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cary

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Easycess Aspiration Pump

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Loseff Medical Designers, Ltd.

    K Number Device Name
    K802025 BALLOON RETENTION CHEST CATHETER