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

    LAP SPONGE

    K Number: K896801 · Decision Dec 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    28
    Review Days
    26

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    Basic Information

    Device Name
    LAP SPONGE
    K Number
    K896801
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Westmark, Sterile Packing Systems, Inc. (Sps)
    Date Received
    December 1, 1989
    Decision Date
    December 27, 1989
    Product Code
    EFQ
    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
    EFQ Gauze/Sponge, Internal

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    Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)

    K Number Device Name
    K896800 IRRIGATION TRAY
    K896799 PARACERVICAL/PUDENDAL TRAYS
    K896559 INFANT FEEDING TUBE
    K896794 SPECIMEN CONTAINER
    K896806 CATHETER PLUG/PROTECTOR
    K896798 TRACHEOSTOMY TRAY
    K896797 SUCTION CATHETER KIT
    K896215 MERCY HIP/KNEE PACK
    K896804 MANIFOLD
    K896556 UNIVERSAL POOLE SUCTION TUBE
    Search all 28 clearances from Westmark, Sterile Packing Systems, Inc. (Sps) →