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

    LOOK VISCODISSECTOR

    K Number: K913530 · Decision Oct 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    25
    Review Days
    74

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    Basic Information

    Device Name
    LOOK VISCODISSECTOR
    K Number
    K913530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Look, Inc.
    Date Received
    August 8, 1991
    Decision Date
    October 21, 1991
    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 Look, Inc.

    K Number Device Name
    K943949 POLYVIOLENE SURGICL SUTURE
    K933686 LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE
    K926586 REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
    K926587 REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
    K926167 POLYVIOLENE SUTURE-REVISED LABELING
    K926588 REVISED LABELING FOR POLYPROPYLENE SUTURE
    K926168 SILK SUTURES-REVISED LABELING
    K903029 STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
    K903584 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K904054 POLYVIOLENE(TM) SUTURE
    Search all 25 clearances from Look, Inc. →