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

    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

    K Number: K991061 · Decision Jun 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    90

    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
    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    K Number
    K991061
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dermaphylyx, Inc.
    Date Received
    March 30, 1999
    Decision Date
    June 28, 1999
    Product Code
    NAE
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

    Similar 510(k) Clearances

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

    MODIFICATION TO ZENIEVA

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

    MODIFICATION TO ZENIEVA

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

    ZENIEVA

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

    GILTECH PLUS HYDROGEL SKIN DRESSING

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

    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

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

    COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)

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

    Other Clearances by Dermaphylyx, Inc.

    K Number Device Name
    K992302 DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
    K991920 DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
    K991933 DERMAPHYLYX FOAM ISLAND DRESSING
    K991609 DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
    K991608 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    K990875 DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
    K990891 DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
    K990438 DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING