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

    DECUBITUS CARE PAD

    K Number: K893969 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    162
    Registration Numbers
    162
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    42

    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
    DECUBITUS CARE PAD
    K Number
    K893969
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Gulftrade Exim, Inc.
    Date Received
    June 2, 1989
    Decision Date
    July 14, 1989
    Product Code
    FWZ
    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
    FWZ Operating Room Accessories Table Tray

    Similar 510(k) Clearances

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

    RETRACTOR ARM CLAMP

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

    'LIL MAC ACCESSORY CLAMP(TM)

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

    CARBON LIGHTS HAND SURGERY TABLE

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

    KAPS POSITIONING ARM

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

    WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)

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

    SPONGE COUNTER

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