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510(k) Data Aggregation

    K Number
    K991592
    Device Name
    KSEA DE LA PLAZA BLEPHAROPLASTY SET
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1999-11-02

    (179 days)

    Product Code
    HNI
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These instruments are manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.
    Device Description
    The Karl Storz De la Plaza Blepharoplasty Set are manually operated orbital retractors. The body contact portions of the KSEA De la Plaza Blepharoplasty Set are composed of surgical grade stainless steel and Polyamide.
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