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510(k) Data Aggregation

    K Number
    K960769
    Device Name
    ACUPUNCTURE NEEDLE PACK
    Manufacturer
    ACU-MED, INC.
    Date Cleared
    1996-07-10

    (135 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACU-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K960651
    Device Name
    CERCLAGE WIRE CRIMP BLOCK
    Manufacturer
    ACU-MED, INC.
    Date Cleared
    1996-05-03

    (78 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACU-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.
    Device Description
    The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable.
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