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

    SITE STERILIZATION TRAYS FOR OPHTHALMIC USE

    K Number: K883098 · Decision Aug 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    30
    Review Days
    27

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    Basic Information

    Device Name
    SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
    K Number
    K883098
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    July 22, 1988
    Decision Date
    August 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 Site Microsurgical Systems, Inc.

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    K921135 IOLAB POWER I.V. POLE
    K920582 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
    K912902 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
    K912739 SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
    K910980 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
    K905620 MODIFIED SITE PERISTALTIC FOOTSWITCH
    K904183 SITE PHACOEMULSIFICATION HANDPIECE
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