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510(k) Data Aggregation

    K Number
    K101538
    Device Name
    HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Date Cleared
    2010-11-05

    (155 days)

    Product Code
    HGY, HGW
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
    Device Description
    The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
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    K Number
    K032845
    Device Name
    EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
    Manufacturer
    THE FIRST YEARS, INC.
    Date Cleared
    2004-04-05

    (207 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-powered Breast Pump to express milk from the breast.
    Device Description
    Easy Comfort ™ Deluxe Manual Breast Pump
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    K Number
    K013226
    Device Name
    EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2001-12-20

    (84 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
    Device Description
    non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
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    K Number
    K011519
    Device Name
    AMEDA HYGIENIKIT
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2001-08-15

    (90 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971231
    Device Name
    WHITE RIVER MINI MANUAL BREAST PUMP
    Manufacturer
    WHITE RIVER CONCEPTS
    Date Cleared
    1997-05-19

    (46 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.
    Device Description
    Not Found
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    K Number
    K962828
    Device Name
    EVERT-IT
    Manufacturer
    GENESIS INDUSTRIES, INC.
    Date Cleared
    1997-02-10

    (206 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Product Code :

    HGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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