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

    NASAL SEPTAL BUTTONS

    K Number: K822637 · Decision Sep 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    127
    Review Days
    28

    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 BUTTONS
    K Number
    K822637
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Abco Dealers, Inc.
    Date Received
    August 31, 1982
    Decision Date
    September 28, 1982
    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

    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
    View all

    Other Clearances by Abco Dealers, Inc.

    K Number Device Name
    K905025 DIGITAL THERMOMETER KITS
    K882304 DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
    K880892 BLOOD COLLECTING NEEDLE AND HOLDERS
    K880894 ALLERGIST SYRINGES
    K872875 STRETCH GAUZE BANDAGES
    K872874 MICROSCOPE COVER GLASSES
    K872797 NON-SKID SHOE COVERS
    K871465 THERMOMETER SHEATHS
    K862726 DISPOSABLE SHOE COVERS AND NURSES CAPS
    K862111 ARMBOARDS, REUSABLE AND DISPOSABLE
    Search all 127 clearances from Abco Dealers, Inc. →