BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERILE BACK SURGICAL GOWN WITH HAND TOWEL

    K Number: K984422 · Decision Apr 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    STERILE BACK SURGICAL GOWN WITH HAND TOWEL
    K Number
    K984422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Sterilization, Inc.
    Date Received
    December 10, 1998
    Decision Date
    April 2, 1999
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    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
    FYA Gown, Surgical

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    Other Clearances by Medical Sterilization, Inc.

    K Number Device Name
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    K843562 MSI SURGI-GRADE DELUXE CUT-DOWN TRAY
    K843561 MSI SURGI-GRADE UNIVERSAL TRACH TRAY
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