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

    MONOJECT SCALE MAGNIFIER

    K Number: K781459 · Decision Oct 24, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    62
    Review Days
    62

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    Basic Information

    Device Name
    MONOJECT SCALE MAGNIFIER
    K Number
    K781459
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5800
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Sherwood Medical Industries
    Date Received
    August 23, 1978
    Decision Date
    October 24, 1978
    Product Code
    HJY
    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
    HJY Reader, Bar, Ophthalmic

    Other Clearances by Sherwood Medical Industries

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    K792014 LANCER L-INA BUFFER, POLYMER, WASH SOLU
    K782077 LANCER ICE CUBE
    K790523 ARGYLE ESOPHAGEAL STETHOSCOPE
    K790196 MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
    K790197 REAGENT KIT, LANCER GLUCOSE
    K781060 MONOJECT ENDOSSEOUS DENTAL IMPLANT
    K772149 LANCER BIOPSY HOLDER
    Search all 62 clearances from Sherwood Medical Industries →