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510(k) Data Aggregation

    K Number
    K070934
    Device Name
    PANOSOL II TRU-BLU, MODEL UBL-417
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Date Cleared
    2007-05-22

    (49 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris
    Device Description
    Not Found
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    K Number
    K041212
    Device Name
    HOUVA 3 PHOTOTHERAPY SYSTEM
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Date Cleared
    2004-06-09

    (30 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
    Device Description
    Not Found
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    K Number
    K982082
    Device Name
    HANDISOL WOUND HEALING
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Date Cleared
    1998-10-28

    (135 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL BIOLOGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The National Biological Corporation Derma-Wand provides photo-therapeutic ultraviolet light. The UVB wand is indicated for dermatologic disorders such as psoriasis and vitiligo. While the UVC wand is indicated for dermatologic disorder in which bactericidal management is desired.
    Device Description
    The grounded sheet metal control housing contains the timer and high voltage components. The UV fluorescent lamps and reflector assembly are enclosed in a light-weight plastic wand designed to allow the user to direct the UV radiation to selected wound areas. There is no physical body contact for treatment.
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