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

    EXETER LIP SEAL

    K Number: K790554 · Decision Apr 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    22

    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
    EXETER LIP SEAL
    K Number
    K790554
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Exeter Medical Labs, Inc.
    Date Received
    March 19, 1979
    Decision Date
    April 10, 1979
    Product Code
    LFA
    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
    LFA Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

    Similar 510(k) Clearances

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

    THE VISUAL SPEECH AID

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Exeter Medical Labs, Inc.

    K Number Device Name
    K781522 THE VISUAL SPEECH AID