BEUDAMED
    Product Code: NOK FDA class 1 21 CFR 878.3800

    Material, External Aesthetic Restoration, No Adhesive

    General, Plastic Surgery

    The non-adhesive external aesthetic restoration material is a surgical specialty device used as a non-implanted external body prosthesis material to restore aesthetic appearance following surgical loss of body parts. It is classified as FDA Class 1 under regulation 878.3800 in the General and Plastic Surgery specialty, and it is GMP exempt. Product code NOK does not require a 510(k) submission.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NOK
    Device Class
    FDA class 1
    Regulation Number
    878.3800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    external aesthetic restoration prosthesis

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.