BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE PACK (PROCEDURAL TRAY/KITS)

    K Number: K882275 · Decision Jul 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    48

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    Basic Information

    Device Name
    STERILE PACK (PROCEDURAL TRAY/KITS)
    K Number
    K882275
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    East Texas Lighthouse For the Blind
    Date Received
    May 31, 1988
    Decision Date
    July 18, 1988
    Product Code
    LRP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRP Tray, Surgical

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    Other Clearances by East Texas Lighthouse For the Blind

    K Number Device Name
    K883376 STERILIZATION WRAP TYPE 22,44,77
    K863733 TOWEL PACK, SURGICAL
    K862062 NONWOVEN SURGICAL DRAPE PACK
    K850067 MEDICAL, DISPOSABLE BEDDING
    K850811 PAD, PRE-OPERATIVE PREPARATION
    K850016 TOWEL PACK, SURGICAL