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

    PHACO NEEDLES 1000-R & 1000-O NEEDLES

    K Number: K923630 · Decision Apr 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    14
    Review Days
    624

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    Basic Information

    Device Name
    PHACO NEEDLES 1000-R & 1000-O NEEDLES
    K Number
    K923630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Specialties, Inc.
    Date Received
    July 21, 1992
    Decision Date
    April 6, 1994
    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 O.R. Specialties, Inc.

    K Number Device Name
    K942607 LAPAROSCOPIC SCISSORS (DISPOSABLE)
    K925671 DISPOSABLE SCLERAL PLUGS
    K923887 JACK'S VENT TUBES
    K923774 DISPOSABLE ENDOILLUMINATOR
    K922355 POLLY'S VITREOUS SCISSORS J-225-S
    K922180 LEWICKY O.R.S. TUBING
    K914038 POLLY'S CUTTER J-225
    K911932 J105 JAMES SURGICAL SYSTEM I/A PACK
    K890195 JAMES SURGICAL SYSTEM J1000
    K891161 VITRECTOMY PACK #J120
    Search all 14 clearances from O.R. Specialties, Inc. →