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510(k) Data Aggregation

    K Number
    K991591
    Device Name
    BIOTHANE PATIENT RESTRAINT
    Manufacturer
    BIOPLASTICS
    Date Cleared
    1999-07-29

    (83 days)

    Product Code
    FMQ, FMO
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPLASTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
    Device Description
    Not Found
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