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

    TotalShield II Surgical Helmet System

    K Number: K192194 · Decision Oct 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    TotalShield II Surgical Helmet System
    K Number
    K192194
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zimmer Surgical, Inc.
    Date Received
    August 13, 2019
    Decision Date
    October 15, 2019
    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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