BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    NONE-GENERIC

    K Number: K940724 · Decision Apr 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    2
    Review Days
    434

    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
    NONE-GENERIC
    K Number
    K940724
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Top Fashion Optical & Sunglasses
    Date Received
    February 18, 1994
    Decision Date
    April 28, 1995
    Product Code
    HQY
    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
    HQY Sunglasses (Non-Prescription Including Photosensitive)

    Similar 510(k) Clearances

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

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MULTI

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Top Fashion Optical & Sunglasses

    K Number Device Name
    K940806 NON-PRESCRIPTION SUNGLASSES