BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WOUND CARE COMPRESSION SYSTEM (WCCS)

    K Number: K960585 · Decision Apr 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    74

    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
    WOUND CARE COMPRESSION SYSTEM (WCCS)
    K Number
    K960585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Suncoast Medical Products, Inc.
    Date Received
    February 12, 1996
    Decision Date
    April 26, 1996
    Product Code
    MCY
    Advisory Committee
    General Hospital
    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
    MCY Wound Dressing Kit

    Similar 510(k) Clearances

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

    DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DRESSING CHANGE TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CIRCULON SYSTEM STEP 1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CIRCULON SYSTEM STEP 2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-PACK PROCEDURE KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all