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

    PHYTACARE ALGINATE HYDROGEL WOUND DRESSING

    K Number: K980132 · Decision Jun 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    1
    Review Days
    162

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    Basic Information

    Device Name
    PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
    K Number
    K980132
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Phytatek Laboratories, Inc.
    Date Received
    January 15, 1998
    Decision Date
    June 26, 1998
    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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