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

    OREX SURGEON'S VEST

    K Number: K961083 · Decision Aug 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    21
    Review Days
    157

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    Basic Information

    Device Name
    OREX SURGEON'S VEST
    K Number
    K961083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thantex Specialties, Inc.
    Date Received
    March 19, 1996
    Decision Date
    August 23, 1996
    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 Thantex Specialties, Inc.

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    K944859 OREX SURGICAL DRAPES
    K944827 OREX SURGEON'S GOWN
    K943034 OREX SHOE COVERS
    K942228 OREX O.R. TOWEL
    K940764 OREX
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