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

    STERILIZATION WRAP TYPE 22,44,77

    K Number: K883376 · Decision Sep 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    STERILIZATION WRAP TYPE 22,44,77
    K Number
    K883376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    East Texas Lighthouse For the Blind
    Date Received
    August 9, 1988
    Decision Date
    September 28, 1988
    Product Code
    FRG
    Advisory Committee
    General Hospital
    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
    FRG Wrap, Sterilization

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    K850067 MEDICAL, DISPOSABLE BEDDING
    K850811 PAD, PRE-OPERATIVE PREPARATION
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