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

    PRE-PACK TENS

    K Number: K813286 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    PRE-PACK TENS
    K Number
    K813286
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cunningham Woodland, Inc.
    Date Received
    November 23, 1981
    Decision Date
    January 22, 1982
    Product Code
    GDY
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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