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

    PANOPLEX HYDROGEL WOUND DRESSING

    K Number: K945005 · Decision Mar 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    PANOPLEX HYDROGEL WOUND DRESSING
    K Number
    K945005
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sage Pharmaceuticals, Inc.
    Date Received
    October 13, 1994
    Decision Date
    March 24, 1995
    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 Sage Pharmaceuticals, Inc.

    K Number Device Name
    K964620 PANOGAUZE NON-WOVEN HYDROGEL DRESSING