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510(k) Data Aggregation

    K Number
    K121322
    Device Name
    CLOSER TO NATURE
    Manufacturer
    MAYBORN GROUP LIMITED
    Date Cleared
    2012-05-31

    (29 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAYBORN GROUP LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from the breast.
    Device Description
    This Single Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 4 alternate settings of sucction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz pod, which fits into "Closer to Nature" lottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered.
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    K Number
    K113664
    Device Name
    CLOSER TO NATURE ELECTRIC BREAST PUMP
    Manufacturer
    MAYBORN GROUP LIMITED
    Date Cleared
    2012-02-17

    (66 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAYBORN GROUP LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tommee Tippee® Closer to Nature® Double Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.
    Device Description
    This Double Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 5 alternate settings of suction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz or 4oz pod, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered. Included with the double electric breast pump motor unit and vacuum system are: - 1 off Carry Bag to hold pump and accessories - 2 off Feeding bottles 5oz with teats as per Mayborn Single Electric Breast Pump K110343 - 2 off Feeding bottles 9oz without teats - 4 off Milk storage lids as per Mayborn Single Electric Breast Pump K110343 - 2 off 4oz Milk storage pods - 4 off 2oz Milk storage pods as per Mayborn Single Electric Breast Pump K110343 - 1 off Milk storage pod tray - 1 off Bottle bag for feeding bottles with milk storage lid - 6 off Disposable Breast pads as per Mayborn Single Electric Breast Pump K110343 - 2 off Spare valves - 2 off Spare Diaphragms 2 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343
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