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

    O&P BIVALVE CRANIAL MOLDING HELMET

    K Number: K063395 · Decision Dec 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    O&P BIVALVE CRANIAL MOLDING HELMET
    K Number
    K063395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthotic & Prosthetic Lab, Inc.
    Date Received
    November 9, 2006
    Decision Date
    December 22, 2006
    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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    Other Clearances by Orthotic & Prosthetic Lab, Inc.

    K Number Device Name
    K021221 O&P CRANICAL MOLDING HELMET