BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EXTRAWEAR, GENTLEMEN'S CHOICE

    K Number: K972428 · Decision Aug 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    EXTRAWEAR, GENTLEMEN'S CHOICE
    K Number
    K972428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Custom Services Intl., Inc.
    Date Received
    June 27, 1997
    Decision Date
    August 25, 1997
    Product Code
    HIS
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIS Condom

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    Other Clearances by Custom Services Intl., Inc.

    K Number Device Name
    K972429 INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
    K972430 EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
    K972427 INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
    K970791 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
    K970767 CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
    K963319 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
    K963322 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
    K963321 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN