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510(k) Data Aggregation

    K Number
    K020718
    Device Name
    SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
    Manufacturer
    PRECISION DYNAMICS CORP.
    Date Cleared
    2002-06-03

    (90 days)

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

    PRECISION DYNAMICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the curd dries and shrinks after the birth.
    Device Description
    The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
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    K Number
    K994353
    Device Name
    SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
    Manufacturer
    PRECISION DYNAMICS CORP.
    Date Cleared
    2000-03-22

    (90 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION DYNAMICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.
    Device Description
    The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.
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    K Number
    K994263
    Device Name
    SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
    Manufacturer
    PRECISION DYNAMICS CORP.
    Date Cleared
    2000-01-24

    (38 days)

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

    PRECISION DYNAMICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn's umbilical cord. The clipper jaws are placed over the "hinge" area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.
    Device Description
    Precision Dynamics Corporation purchases the packaged umbilical cord clamp clipper (non-sterile) from DeRoyal Industries. Precision Dynamics Corporation upon receipt of the non-sterile finished product from DeRoyal Industries plans to distribute this device as the Securline ® Umbilical Cord Clamp Clipper.
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    K Number
    K990737
    Device Name
    'ECURLINE UMBILICAL CORD CLAMP #3500
    Manufacturer
    PRECISION DYNAMICS CORP.
    Date Cleared
    1999-04-06

    (32 days)

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

    PRECISION DYNAMICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a Newborn at delivery. The device is used to hold the cord securely and prevent blodd loss and seepage as the cord dries and shrinks after the birth.
    Device Description
    Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp.
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