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

    HYDROBRUSH (TM) KERATOME

    K Number: K971078 · Decision Jan 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    305

    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
    HYDROBRUSH (TM) KERATOME
    K Number
    K971078
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medjet, Inc.
    Date Received
    March 24, 1997
    Decision Date
    January 23, 1998
    Product Code
    HQS
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQS Burr, Corneal, Ac-Powered