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

    MALE CONDOM

    K Number: K822088 · Decision Nov 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    10
    Review Days
    113

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    Basic Information

    Device Name
    MALE CONDOM
    K Number
    K822088
    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
    July 13, 1982
    Decision Date
    November 3, 1982
    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.

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    K874791 CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)
    K880202 OKAMOTO CONDOMS
    K874718 STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
    K802354 PROPHYLACTIC W/SPERMICIDAL LUBRICANT