BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SHADOW MEDAL LOCATOR

    K Number: K953277 · Decision Apr 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    263

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    Basic Information

    Device Name
    SHADOW MEDAL LOCATOR
    K Number
    K953277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fatswith Intl., Inc.
    Date Received
    July 13, 1995
    Decision Date
    April 1, 1996
    Product Code
    HPM
    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
    HPM Locator, Metal, Electronic

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