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510(k) Data Aggregation

    K Number
    K100343
    Device Name
    PAP-CAP
    Manufacturer
    PUR-SLEEP, INC.
    Date Cleared
    2010-04-23

    (77 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    PUR-SLEEP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PAP-Cap™ headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and /or home environments. The headgear is single patient, multi-use.
    Device Description
    The Pur-Sleep PAP-Cap™ is a simple alternative headgear (with an integrated but fully detachable chin strap) designed to be used with standard patient interfaces, i.e., full face mask, nasal mask and nasal pillow and cannula devices. It is designed to be adjusted to optimize fit and patient comfort. It is adaptable to many models of CPAP mask styles.
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