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

    OCU-GUARD AND OCU-GUARD SUPPLE

    K Number: K983581 · Decision Nov 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    26
    Review Days
    24

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    Basic Information

    Device Name
    OCU-GUARD AND OCU-GUARD SUPPLE
    K Number
    K983581
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.3340
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Vascular, Inc.
    Date Received
    October 13, 1998
    Decision Date
    November 6, 1998
    Product Code
    HQX
    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
    HQX Implant, Orbital, Extra-Ocular

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    Other Clearances by Bio-Vascular, Inc.

    K Number Device Name
    K002233 BVI SLING
    K992537 PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
    K983602 CV PERI-GUARD AND VASCU-GUARD
    K983162 PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
    K981624 FLO-THRU
    K982282 DURA-GUARD - DURAL REPAIR PATCH
    K971726 CV PERI-GUARD - CARDIOVASCULAR PATCH
    K973706 DURA-GUARD-DURAL REPAIR PATCH
    K973552 OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
    K971048 PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
    Search all 26 clearances from Bio-Vascular, Inc. →