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

    NASAL SEPTAL BUTTON

    K Number: K972060 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    33
    Review Days
    31

    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
    NASAL SEPTAL BUTTON
    K Number
    K972060
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Medical Products, Inc.
    Date Received
    June 2, 1997
    Decision Date
    July 3, 1997
    Product Code
    LFB
    Advisory Committee
    Unknown
    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
    LFB Button, Nasal Septal

    Similar 510(k) Clearances

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

    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILMED NASAL SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown

    MICROMEDICS NASAL SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown

    HOOD NASAL SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown

    INVOTEC SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMEGA NASAL SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Boston Medical Products, Inc.

    K Number Device Name
    K091135 RUTTER SUPRA STOMAL STENTS
    K972317 MONTGOMERY THYROPLASTY IMPLANT SYSTEM
    K972459 RHINOCELL NASAL PACKINGS
    K972096 BIVALVE NASAL SPLINT
    K972078 POST-STOP EPISTAXIS CATHETER
    K972092 NASAL AIRWAY SPLINT
    K972151 DOYLE COMBO NASAL AIRWAY SPLINT
    K972082 CUSTOM NASAL SPLINT
    K972076 EPI-MAX EPISTAXIS CATHETER
    K972077 EPI-STOP EPISTAXIS CATHETER
    Search all 33 clearances from Boston Medical Products, Inc. →