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

    VITOFIT

    K Number: K821260 · Decision Jun 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    54

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    Basic Information

    Device Name
    VITOFIT
    K Number
    K821260
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Selomas, Inc.
    Date Received
    April 30, 1982
    Decision Date
    June 23, 1982
    Product Code
    FQL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FQL Stocking, Medical Support (For General Medical Purposes)

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    Other Clearances by Selomas, Inc.

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    K861215 GAUZE SPONGES USP TYPE VII
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    K821490 SILKAFIX ADHESIVE PLASTER
    K821257 SELOFIX
    K812501 OPRAFLEX