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

    DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)

    K Number: K962439 · Decision Sep 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
    K Number
    K962439
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Hamer Assoc., Inc.
    Date Received
    June 24, 1996
    Decision Date
    September 3, 1996
    Product Code
    MGQ
    Advisory Committee
    Unknown
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Richard Hamer Assoc., Inc.

    K Number Device Name
    K951325 COMFEEL PLUS PRESSURE RELIEF DRESSING
    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