BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EPI-MAX EPISTAXIS CATHETER

    K Number: K972076 · Decision Jun 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    33
    Review Days
    23

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    Basic Information

    Device Name
    EPI-MAX EPISTAXIS CATHETER
    K Number
    K972076
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4100
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Medical Products, Inc.
    Date Received
    June 3, 1997
    Decision Date
    June 26, 1997
    Product Code
    EMX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EMX Balloon, Epistaxis

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    Other Clearances by Boston Medical Products, Inc.

    K Number Device Name
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    K972096 BIVALVE NASAL SPLINT
    K972078 POST-STOP EPISTAXIS CATHETER
    K972092 NASAL AIRWAY SPLINT
    K972151 DOYLE COMBO NASAL AIRWAY SPLINT
    K972082 CUSTOM NASAL SPLINT
    K972060 NASAL SEPTAL BUTTON
    K972077 EPI-STOP EPISTAXIS CATHETER
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