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

    SURGICAL PREP RAZOR

    K Number: K874370 · Decision Nov 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    18

    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
    SURGICAL PREP RAZOR
    K Number
    K874370
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Derma-Safe Co.
    Date Received
    October 26, 1987
    Decision Date
    November 13, 1987
    Product Code
    LWK
    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
    LWK Razor, Surgical

    Similar 510(k) Clearances

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

    3M(TM) SURGICAL SLIPPER, 9660 SERIES

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

    SURGICAL CLIPPER

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

    SURGICAL PREP RAZOR, STRAIGHT TYPE

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

    Other Clearances by Derma-Safe Co.

    K Number Device Name
    K874234 SURGICAL PREP RAZOR, STRAIGHT TYPE