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

    WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

    K Number: K961316 · Decision Jul 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    4
    Review Days
    101

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    Basic Information

    Device Name
    WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
    K Number
    K961316
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Renaissance Pharmaceutical, Inc.
    Date Received
    April 5, 1996
    Decision Date
    July 15, 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 Renaissance Pharmaceutical, Inc.

    K Number Device Name
    K961766 WOUND HYDROGEL & STERILE WOUND HYDROGEL
    K954384 WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
    K941339 STERILE WOUND HYDROGEL DRESSING