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

    WHITE KNIGHT SURGEON'S VEST

    K Number: K951984 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    WHITE KNIGHT SURGEON'S VEST
    K Number
    K951984
    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
    White Knight Healthcare
    Date Received
    April 27, 1995
    Decision Date
    July 25, 1995
    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 White Knight Healthcare

    K Number Device Name
    K943809 MONOGARD FACE SHIELD
    K942577 SURGICAL TIP CLEANER
    K942576 CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE
    K934969 DUALGARD FACE SHIELD