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

    DERMABRADERS

    K Number: K821485 · Decision Jun 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    DERMABRADERS
    K Number
    K821485
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Spire Medical, Inc.
    Date Received
    May 18, 1982
    Decision Date
    June 10, 1982
    Product Code
    GFF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GFF Bur, Surgical, General & Plastic Surgery

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    Other Clearances by Spire Medical, Inc.

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