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510(k) Data Aggregation

    K Number
    K060340
    Device Name
    ORAMAGIC PLUS ORAL WOUND RINSE
    Manufacturer
    MPM MEDICAL, INC.
    Date Cleared
    2006-05-10

    (89 days)

    Product Code
    OLR, MGO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
    Device Description
    OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
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    K Number
    K024180
    Device Name
    ORAMAGICRX ORAL WOUND RINSE
    Manufacturer
    MPM MEDICAL, INC.
    Date Cleared
    2003-03-14

    (86 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.
    Device Description
    OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.
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    K Number
    K020540
    Device Name
    REGENECARE WOUND GEL
    Manufacturer
    MPM MEDICAL, INC.
    Date Cleared
    2002-11-01

    (255 days)

    Product Code
    MGQ, MGO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
    Device Description
    Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.
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    K Number
    K992074
    Device Name
    MPM REGENECARE WOUND GEL
    Manufacturer
    MPM MEDICAL, INC.
    Date Cleared
    1999-12-23

    (188 days)

    Product Code
    MGQ, MGO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
    Device Description
    MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes. Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
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    K Number
    K962160
    Device Name
    MPM HYDROGEL DRESSING (NON-STERILE)
    Manufacturer
    MPM MEDICAL, INC.
    Date Cleared
    1996-06-26

    (22 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
    Device Description
    The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
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