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510(k) Data Aggregation

    K Number
    K250890

    Validate with FDA (Live)

    Device Name
    SBC1 Cream
    Manufacturer
    Sioxmed, LLC
    Date Cleared
    2026-01-12

    (293 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K242406
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBC1 Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on breached or compromised skin or open sores.

    Device Description

    SBC1 Cream is a fragrance free, preserved, non-sterile, topical skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. SBC1 Cream supports a moist environment. SBC1 Cream is provided prescription only in various sizes for single patient use.

    AI/ML Overview

    N/A

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