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510(k) Data Aggregation

    K Number
    K043533
    Device Name
    SURGICAL DESIGN CIRCUMCISION CLAMP
    Manufacturer
    SURGICAL DESIGN, INC.
    Date Cleared
    2005-04-01

    (100 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.
    Device Description
    The Surgical Design Gomco Circumcision Clamp is a disposable medical device that is constructed of Chrome Plated Brass. The device will be sold Non Sterile for further processing(i.e. Packaging and Sterilization) by the Final Distributors. We do not intend to sell these devices to the end users.
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