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510(k) Data Aggregation

    K Number
    K034015
    Device Name
    EARLOOP PROCEDURE MASK
    Manufacturer
    MEDIPACK MEDICAL PACKAGING MFG. CO.
    Date Cleared
    2004-02-20

    (58 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPACK MEDICAL PACKAGING MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.
    Device Description
    Not Found
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    K Number
    K993764
    Device Name
    MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
    Manufacturer
    MEDIPACK MEDICAL PACKAGING MFG. CO.
    Date Cleared
    1999-12-16

    (38 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPACK MEDICAL PACKAGING MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
    Device Description
    The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.
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