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

    SILON DUAL-DRESS

    K Number: K990042 · Decision Mar 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    10
    Review Days
    72

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    Basic Information

    Device Name
    SILON DUAL-DRESS
    K Number
    K990042
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio Med Sciences, Inc.
    Date Received
    January 6, 1999
    Decision Date
    March 19, 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 Bio Med Sciences, Inc.

    K Number Device Name
    K023136 OLEEVA FABRIC
    K002109 OLEEVA FOAM
    K982036 SILON SCAR STRIPS
    K952546 SILON SILICONE TEXTILE COMPOSITE
    K946362 SILON SILICONE FOAM SHEETING
    K945892 SILON(R) SILICONE THERMOPLASTIC SHEETING
    K932214 SILON SILICONE GEL SHEET
    K923150 SILON TRANSPARENT WOUND DRESSINGS
    K912032 SILON(TM) TRANSPARENT WOUND DRESSING