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510(k) Data Aggregation

    K Number
    DEN090005
    Device Name
    PRINEO SKIN CLOSURE SYSTEM
    Manufacturer
    CLOSURE MEDICAL CORP.
    Date Cleared
    2010-04-30

    (402 days)

    Product Code
    OMD
    Regulation Number
    878.4011
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLOSURE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002338
    Device Name
    LIQUIDERM LIQUID ADHESIVE BANDAGE
    Manufacturer
    CLOSURE MEDICAL CORP.
    Date Cleared
    2001-01-29

    (181 days)

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

    CLOSURE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991923
    Device Name
    SOOTHE-N-SEAL CANKER SORE RELIEF
    Manufacturer
    CLOSURE MEDICAL CORP.
    Date Cleared
    1999-09-02

    (87 days)

    Product Code
    MZW
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLOSURE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.
    Device Description
    SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application. SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life.
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    K Number
    K980159
    Device Name
    OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
    Manufacturer
    CLOSURE MEDICAL CORP.
    Date Cleared
    1998-04-09

    (83 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLOSURE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Octyldent® is intended for use as an adhesive for the temporary fixing of periodontal polymer or fibers in periodontal pockets.
    Device Description
    Not Found
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