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510(k) Data Aggregation

    K Number
    K961323
    Device Name
    LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
    Manufacturer
    ACME UNITED CORP.
    Date Cleared
    1996-06-19

    (75 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACME UNITED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds, while Lycfoam®"C" would be used to treat lightly to moderately exuding wounds.
    Device Description
    Lyofoam® Extra "C" Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with activated carbon for odor absorption.
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    K Number
    K961452
    Device Name
    LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
    Manufacturer
    ACME UNITED CORP.
    Date Cleared
    1996-05-31

    (45 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACME UNITED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds.
    Device Description
    Lyofoam® Extra "A", Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with adhesive boarder.
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