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

    PADGETT AIR DERMATOME, MODEL A

    K Number: K951085 · Decision May 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    PADGETT AIR DERMATOME, MODEL A
    K Number
    K951085
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Padgett Instruments, Inc.
    Date Received
    March 9, 1995
    Decision Date
    May 15, 1995
    Product Code
    GFD
    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
    GFD Dermatome

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