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

    PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR

    K Number: K893199 · Decision Jun 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    276
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    51

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
    K Number
    K893199
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Allergan Medical Optics
    Date Received
    April 26, 1989
    Decision Date
    June 16, 1989
    Product Code
    HNR
    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
    HNR Forceps, Ophthalmic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HNR), ordered by most recent decision date.

    STEPHENS DISPOSABLE FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ALCON FOLDING FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SOFT LENS FOLDING BLOCK

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MCDONALD FOLDING FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BRADBURY INTRAOCULAR RETINAL KIT CAT #200

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IOL IMPLANTATION FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Allergan Medical Optics

    K Number Device Name
    K951462 AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
    K941603 AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
    K930320 AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
    K925254 AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
    K924235 AMO ELITE
    K911998 MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM