BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    PROFIL CONDOM (RUBBER LATEX)

    K Number: K895894 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    70

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PROFIL CONDOM (RUBBER LATEX)
    K Number
    K895894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Rfsu
    Date Received
    October 5, 1989
    Decision Date
    December 14, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIS), ordered by most recent decision date.

    Male Latex Condom HA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LifeStyles® HydraFeel Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Natural rubber latex male condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Lelo Hex Lubricated Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    0.04 ZERO ZERO FOUR Male Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Rfsu

    K Number Device Name
    K902907 MAMBA CONDOM (RUBBER LATEX)
    K894533 CONDOM (RUBBER LATEX) KILROY
    K895028 BIRDS'N BEES CONDOMS
    K894534 CONDOM (RUBBER LATEX) OKEIDO