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

    POSTERIOR CAPSULE SHIELD

    K Number: K950798 · Decision May 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    17
    Review Days
    90

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    Basic Information

    Device Name
    POSTERIOR CAPSULE SHIELD
    K Number
    K950798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oasis Medical, Inc.
    Date Received
    February 21, 1995
    Decision Date
    May 22, 1995
    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 Oasis Medical, Inc.

    K Number Device Name
    K213988 SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
    K162361 Soft Plug Extended Duration 180 Canalicular Plug
    K032297 DISPOSABLE N-PE MICKROKERATOME BLADES
    K030401 DISPOSABLE M2-PE MICROKERATOME BLADES
    K022205 DISPOSABLE N-PE MICROKERATOME BLADES
    K013613 SOFT PLUG ABSORBABLE PLUG-SA
    K003820 DISPOSABLE CB-PE MICROKERATOME BLADES
    K001176 DISPOSABLE MICROKERATOME BLADES-PE
    K980437 SILICONE PUNCTAL PLUG
    K950241 OPHTHALMIC SPONGES
    Search all 17 clearances from Oasis Medical, Inc. →