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510(k) Data Aggregation

    K Number
    K962807
    Device Name
    AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
    Manufacturer
    AMERICAN SURGICAL SPONGES
    Date Cleared
    1997-05-02

    (288 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN SURGICAL SPONGES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.
    Device Description
    The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.
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