BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

    K Number: K991287 · Decision Jun 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
    K Number
    K991287
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions Group Plc
    Date Received
    April 14, 1999
    Decision Date
    June 29, 1999
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Advanced Medical Solutions Group Plc

    K Number Device Name
    K991630 ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET