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

    PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI

    K Number: K882381 · Decision Jul 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    19
    Review Days
    28

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    Basic Information

    Device Name
    PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
    K Number
    K882381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pioneering Technologies, Inc.
    Date Received
    June 9, 1988
    Decision Date
    July 7, 1988
    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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