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

    HM-880 I

    K Number: K932817 · Decision Mar 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    273

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    Basic Information

    Device Name
    HM-880 I
    K Number
    K932817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hill-Med, Inc.
    Date Received
    June 9, 1993
    Decision Date
    March 9, 1994
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Hill-Med, Inc.

    K Number Device Name
    K993991 HM-930 ELECTROSURGICAL UNIT
    K981781 ELECTROSURGICAL UNIT
    K961473 HM-88011 SOLID STATE ELECTR SURGICAL UNIT
    K951718 HM-SPIRO
    K940140 HM-CRYO
    K932782 HM-0660
    K932896 HM-0690 COLPOSCOPE
    K932818 HM-880
    K932720 HM-0970