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

    AQUACEL SURGICAL PREP PADS

    K Number: K861937 · Decision Jun 6, 1986
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    17

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    Basic Information

    Device Name
    AQUACEL SURGICAL PREP PADS
    K Number
    K861937
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Advanced Ortho-Technology, Inc.
    Date Received
    May 20, 1986
    Decision Date
    June 6, 1986
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Advanced Ortho-Technology, Inc.

    K Number Device Name
    K854241 AOT EXTERNAL COMPRESS DEVICE
    K854344 AQUACEL SURGICAL PREP PADS