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510(k) Data Aggregation

    K Number
    K990179
    Device Name
    BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
    Manufacturer
    NORTRADE MEDICAL, INC.
    Date Cleared
    1999-08-13

    (205 days)

    Product Code
    MGQ,MGO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD

    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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing" and "Burnfree Pain Relieving Gel" products. It confirms that the devices are substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

    This document does not contain information about:

    1. Acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, or details of a study.
    3. Number of experts, their qualifications, or adjudication methods.
    4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    5. Standalone algorithm performance.
    6. Type of ground truth used.
    7. Sample size for the training set or how its ground truth was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and study details based on the provided text.

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