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

    BARRIER GOWN, KOOL-GARD BACKLESS GOWN

    K Number: K952115 · Decision Sep 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    20
    Review Days
    143

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    Basic Information

    Device Name
    BARRIER GOWN, KOOL-GARD BACKLESS GOWN
    K Number
    K952115
    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
    American Threshold Industries, Inc.
    Date Received
    May 5, 1995
    Decision Date
    September 25, 1995
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by American Threshold Industries, Inc.

    K Number Device Name
    K971483 SECURE-WRAP (TM) STERILIZATION WRAP
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    K952114 KOOL GARD SINGLES GOWN
    K952116 COVER GOWN
    K934085 MODIFICATION OF SURGICAL EYESHIELD MASK
    K915530 NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
    K915740 DISPOSABLE O.R. TOWEL, STERILE
    K912110 DISPOSABLE O.R. TOWEL
    K894383 DISPOSABLE SHOE COVER
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