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510(k) Data Aggregation

    K Number
    K030339
    Device Name
    CAUTERY TIP CLEANER, MODEL-TC-100
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Date Cleared
    2003-03-07

    (35 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASPEN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.
    Device Description
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    K Number
    K020304
    Device Name
    DISPOSABLE LIGHT HANDLE AND ADAPTOR
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Date Cleared
    2002-02-14

    (16 days)

    Product Code
    FTA
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASPEN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Light Handle is a sterile product. It is intended to be used as an accessory to Surgical Lamps. This Disposable Handle provides a sterile interface between the operating room Surgical Lamp (non-sterile), and the Surgeon or Scrub Nurse (sterile)
    Device Description
    Not Found
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