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

    OKAMOTO CONDOMS

    K Number: K880202 · Decision Feb 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    10
    Review Days
    38

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    Basic Information

    Device Name
    OKAMOTO CONDOMS
    K Number
    K880202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Schmid Laboratories, Inc.
    Date Received
    January 19, 1988
    Decision Date
    February 26, 1988
    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 Schmid Laboratories, Inc.

    K Number Device Name
    K897140 THIN CONDOM RAMSES & SHEIK
    K900679 MINT SCENTED CONDOMS
    K884399 STANDARD LATEX CONDOM
    K882893 CONDOMS (RAMSES, SHEIK AND KOROMEX)
    K880820 OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED
    K874791 CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)
    K874718 STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
    K822088 MALE CONDOM
    K802354 PROPHYLACTIC W/SPERMICIDAL LUBRICANT