BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE SPONGE BOWLS

    K Number: K800440 · Decision Apr 29, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    221
    Registration Numbers
    221
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    STERILE SPONGE BOWLS
    K Number
    K800440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6730
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Premium Plastics, Inc.
    Date Received
    February 28, 1980
    Decision Date
    April 29, 1980
    Product Code
    FNY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FNY Basin, Emesis

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    K893135 GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
    K850285 GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
    K771448 STERILE SUTURE REMOVAL KIT