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

    VISITEC OPHTHALMIC FLUID DISTRIB- SET

    K Number: K843487 · Decision Mar 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    49
    Review Days
    188

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    Basic Information

    Device Name
    VISITEC OPHTHALMIC FLUID DISTRIB- SET
    K Number
    K843487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Visitec Co.
    Date Received
    September 6, 1984
    Decision Date
    March 13, 1985
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Visitec Co.

    K Number Device Name
    K953394 VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
    K945114 VISITEC SCLERAL PLUG
    K945738 VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
    K945172 VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
    K942234 VISITEC PRECISE-POINT
    K934269 FIBEROPTIC ILLUMINATED INSTRUMENTS
    K940210 VISITEC EYE PAD
    K933872 VISI-SPEAR EYE SPONGE
    K923972 OPHTHALMIC FLUID DISTRIBUTION SETS
    K922530 VISITEC MICROSURGICAL SUTURE
    Search all 49 clearances from Visitec Co. →