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

    CHOICE

    K Number: K864482 · Decision Dec 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    7
    Review Days
    39

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    Basic Information

    Device Name
    CHOICE
    K Number
    K864482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Select Sources, Inc.
    Date Received
    November 13, 1986
    Decision Date
    December 22, 1986
    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 Select Sources, Inc.

    K Number Device Name
    K884328 CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)
    K883705 FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
    K883078 INSULIN SYRINGE
    K883033 PISTON SYRINGE WITH NEEDLE
    K880919 (CHOICE) ALSO (KONDUM)
    K863190 CHOICE CONDOM