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510(k) Data Aggregation

    K Number
    K981902
    Device Name
    SPENCO SILICONE GEL SHEET
    Manufacturer
    SPENCO MEDICAL CORP.
    Date Cleared
    1998-06-25

    (24 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPENCO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spenco Silicone Gel Sheet is indicated for: - Use as a scar management dressing on old and new 1. hyperthropic or keloid scars. - infected wounds Not to be used on ત્વે. - Is not indicated for use on 3rd degree burns - The device can be used by layman, safely when following the instructions-for use included with the product.
    Device Description
    Spenco Silicone Gel Sheet
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