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

    PERFECTEMP OPHTHALMIC CAUTERY

    K Number: K801078 · Decision Jun 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    PERFECTEMP OPHTHALMIC CAUTERY
    K Number
    K801078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Medical Products Development, Inc.
    Date Received
    May 7, 1980
    Decision Date
    June 4, 1980
    Product Code
    HQP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQP Unit, Cautery, Thermal, Battery-Powered

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    Other Clearances by Medical Products Development, Inc.

    K Number Device Name
    K810013 MULTIPERFECTEMP CAUTERY
    K810012 MULTIMICRO SURGICAL CAUTERY
    K810016 REPLACABLE BATTERY PERFECTEMP CAUTERY
    K803067 SURG-FLEX 10 LIGHT
    K810015 MULTIHI-TEMP CAUTERY
    K810014 REPLACABLE BATTERY HI-TEMP CAUTERY
    K802942 HITEMP. TM 2 LOOPTIP CAUTERY
    K810018 SURG-FLEX 5 SURGICAL LIGHT
    K810019 SURG-FLEX 15 SURGICAL LIGHT
    K810017 MICROSURG CAUTERY
    Search all 13 clearances from Medical Products Development, Inc. →