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510(k) Data Aggregation

    K Number
    K041060
    Device Name
    E-Z LUBRICATING JELLY
    Manufacturer
    CHESTER LABS, INC.
    Date Cleared
    2004-05-07

    (14 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTER LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Z Lubricating Jelly is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. E-Z Lubricating Jelly (sterile) is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field Is required.
    Device Description
    Not Found
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    K Number
    K001705
    Device Name
    STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
    Manufacturer
    CHESTER LABS, INC.
    Date Cleared
    2000-06-29

    (24 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTER LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001593
    Device Name
    MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
    Manufacturer
    CHESTER LABS, INC.
    Date Cleared
    2000-06-14

    (22 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTER LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K944598
    Device Name
    GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
    Manufacturer
    CHESTER LABS, INC.
    Date Cleared
    1996-05-07

    (596 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTER LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K944599
    Device Name
    GRAHAM-FIELD CONDUCTIVE ECG SPRAY
    Manufacturer
    CHESTER LABS, INC.
    Date Cleared
    1996-05-07

    (596 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTER LABS, INC.

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

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