BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MARINA MEDICAL FINGER PROTECTORS

    K Number: K042534 · Decision May 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    235

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    Basic Information

    Device Name
    MARINA MEDICAL FINGER PROTECTORS
    K Number
    K042534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marina Medical Instruments, Inc.
    Date Received
    September 17, 2004
    Decision Date
    May 10, 2005
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Marina Medical Instruments, Inc.

    K Number Device Name
    K031463 MARINA MEDICAL SILICONE PESSARY
    K021876 MAS WITH OR WITHOUT SYRINGE
    K023725 HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
    K010296 UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450