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510(k) Data Aggregation

    K Number
    K100139
    Device Name
    SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
    Manufacturer
    SAFELIFE CORP.
    Date Cleared
    2010-05-04

    (105 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFELIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.
    Device Description
    The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices.
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