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

    VISOPROTECT: OCCULAR SHIELD

    K Number: K850099 · Decision Mar 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    68

    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
    VISOPROTECT: OCCULAR SHIELD
    K Number
    K850099
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4440
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Rockway Enterprises, Inc.
    Date Received
    January 11, 1985
    Decision Date
    March 20, 1985
    Product Code
    HMP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HMP Pad, Eye

    Similar 510(k) Clearances

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

    EYE PAD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STERILE,DISPOSABLE EYE DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EYE PAD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DONALDSON NATURAL EYEPATCH 'PATIENT PAK'

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LIDSPLINT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all