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510(k) Data Aggregation

    K Number
    K990178
    Device Name
    BURNFREE PAIN RELIEVING GEL, MODEL 4B
    Manufacturer
    NORTRADE MEDICAL, INC.
    Date Cleared
    1999-08-13

    (205 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
    2. Relieves Pain.
    3. Cools and Soothes.
    4. Moistens.
    5. Non-Irritating
    6. Bacteriostatic
    Device Description

    BURNFREE PAIN RELIEVING GEL

    AI/ML Overview

    I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing," "Burnfree 1/8 oz. Sterile Pain Relieving Gel," and "Burnfree Pain Relieving Gel."

    This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

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