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510(k) Data Aggregation

    K Number
    K102600
    Device Name
    SIMPLYGO BREAST PUMP
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2010-12-22

    (103 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.
    Device Description
    The SimplyGo™ Breast Pump Kit is an electrically operated suction device.
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    K Number
    K100435
    Device Name
    AMEDA PLATINUM BREAST PUMP
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2010-05-28

    (101 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.
    Device Description
    The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.
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    K Number
    K092770
    Device Name
    SIMPLYGO HANDS FREE BREAST PUMP
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2009-10-09

    (30 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.
    Device Description
    Not Found
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    K Number
    K082307
    Device Name
    EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2008-09-11

    (29 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Comfort Select Performance Breast Pump and Comfort Select Performance Dual Breast Pump are personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women.
    Device Description
    Not Found
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    K Number
    K053493
    Device Name
    BERRY FRUITY TEETHER
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2006-02-22

    (69 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
    Device Description
    Not Found
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    K Number
    K052909
    Device Name
    EVENFLO ELAN BREAST PUMP
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2005-11-01

    (15 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.
    Device Description
    Not Found
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    K Number
    K022933
    Device Name
    EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
    Manufacturer
    EVENFLO COMPANY, INC.
    Date Cleared
    2002-12-02

    (89 days)

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

    EVENFLO COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast. The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are battery/electric powered suction device used to express milk from the breast of lactating women.
    Device Description
    The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time.
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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?
    Applicant Name (Manufacturer) :

    EVENFLO COMPANY, INC.

    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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