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

    COPC BAND

    K Number: K021594 · Decision Nov 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    547

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    Basic Information

    Device Name
    COPC BAND
    K Number
    K021594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Center For Orthotic and Prosthetic Care,Llc
    Date Received
    May 15, 2002
    Decision Date
    November 13, 2003
    Product Code
    MVA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVA Orthosis, Cranial

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