BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    DEGANIA SILICONE INDENTI LOOPS

    K Number: K964547 · Decision Jan 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    19
    Review Days
    56

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    Basic Information

    Device Name
    DEGANIA SILICONE INDENTI LOOPS
    K Number
    K964547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Degania Silicone , Ltd.
    Date Received
    November 13, 1996
    Decision Date
    January 8, 1997
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXC Clamp, Vascular

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    K141631 AQUARIUS EXTENSION FEEDING SET
    K132686 AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
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