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510(k) Data Aggregation

    K Number
    K974227
    Device Name
    HOSPITAL'S CLAMP
    Manufacturer
    Date Cleared
    1997-12-12

    (30 days)

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

    GPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DISPOSABLE, STERILE UMBILICAL CORD CLAMP TO BE USED FOR OBSTETRICS USE ONLY. UMBILICAL CORD CLAMP WITH SIDE FASTENERS TO PREVENT THE UMBILICAL CORD FROM GOING OUT OF THE BLOCKING COMBS IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL OPENING.
    Device Description
    Not Found
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    K Number
    K974228
    Device Name
    HOSPITAL'S SPEC
    Manufacturer
    Date Cleared
    1997-12-12

    (30 days)

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

    GPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DISPOSABLE STERILE VAGINAL SPECULUM USED TO EXAMINE THE INTERIOR OF THE VAGINA DURING GYNECOLOGICAL PROCEDURES HAS A REGULATING SCREW TO ALLOW A GRADUAL OPENING
    Device Description
    Vaginal Speculum
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