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

    HM-CRYO

    K Number: K940140 · Decision Jun 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    10
    Review Days
    167

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    Basic Information

    Device Name
    HM-CRYO
    K Number
    K940140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hill-Med, Inc.
    Date Received
    January 11, 1994
    Decision Date
    June 27, 1994
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, 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
    K932782 HM-0660
    K932896 HM-0690 COLPOSCOPE
    K932817 HM-880 I
    K932818 HM-880
    K932720 HM-0970