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

    DERMALEX OR NATRAWOOL SKIN PRESSURE PROT

    K Number: K801195 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    374
    Registration Numbers
    374
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    24

    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
    DERMALEX OR NATRAWOOL SKIN PRESSURE PROT
    K Number
    K801195
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Stock Wild & Co.
    Date Received
    May 16, 1980
    Decision Date
    June 9, 1980
    Product Code
    FMP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMP Protector, Skin Pressure

    Similar 510(k) Clearances

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

    Invictus Medical GelShield

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMFEEL PLUS PRESSURE RELIEF DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDSURG STERILE IMAGING PRODUCTS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DECUBICARE PADS & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEEL OR ELBOW PROTECTOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPENCO DERMAL PADS

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all