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

    COMFEEL PLUS TRANSPARENT DRESSING

    K Number: K942283 · Decision Jul 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    COMFEEL PLUS TRANSPARENT DRESSING
    K Number
    K942283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Richard Hamer Assoc., Inc.
    Date Received
    May 11, 1994
    Decision Date
    July 29, 1994
    Product Code
    KMF
    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
    KMF Bandage, Liquid

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    Other Clearances by Richard Hamer Assoc., Inc.

    K Number Device Name
    K962439 DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
    K951325 COMFEEL PLUS PRESSURE RELIEF DRESSING
    K950934 MPM HYDROGEL DRESSING
    K951327 COMFEEL PLUS CONTOUR DRESSING
    K942573 COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
    K941263 COMFEEL PLUS WOUND DRESSING
    K934839 MESALT STERILE DRESSING