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

    REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT

    K Number: K993396 · Decision Feb 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    130

    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
    REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
    K Number
    K993396
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Remed Pharma
    Date Received
    October 8, 1999
    Decision Date
    February 15, 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

    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 Remed Pharma

    K Number Device Name
    K993389 REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
    K993403 REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
    K993409 REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
    K993408 REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
    K993405 REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
    K993395 REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
    K993404 REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
    K993390 REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT