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

    COMFEEL PLUS PRESSURE RELIEF DRESSING

    K Number: K951325 · Decision Jul 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    363
    Registration Numbers
    363
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    130

    Basic Information

    Device Name
    COMFEEL PLUS PRESSURE RELIEF DRESSING
    K Number
    K951325
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RICHARD HAMER ASSOC., INC.
    Date Received
    March 23, 1995
    Decision Date
    July 31, 1995
    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

    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

    SCANLAN VASCU-STATT

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

    Other Clearances by RICHARD HAMER ASSOC., INC.

    K Number Device Name
    K962439 DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
    K950934 MPM HYDROGEL DRESSING
    K951327 COMFEEL PLUS CONTOUR DRESSING
    K942283 COMFEEL PLUS TRANSPARENT DRESSING
    K942573 COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
    K941263 COMFEEL PLUS WOUND DRESSING
    K934839 MESALT STERILE DRESSING