BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED

    K Number: K000040 · Decision Mar 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    75

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    Basic Information

    Device Name
    INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
    K Number
    K000040
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Indus Medicare , Ltd.
    Date Received
    January 6, 2000
    Decision Date
    March 21, 2000
    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 Indus Medicare , Ltd.

    K Number Device Name
    K022614 INVIGRA
    K020223 INVIGRA
    K000038 INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
    K000039 INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
    K993693 INVIGRA
    K992438 INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
    K991374 INVIGRA