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

    CROUCH CORNEAL PROTECTOR

    K Number: K811577 · Decision Aug 7, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    10
    Review Days
    63

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    Basic Information

    Device Name
    CROUCH CORNEAL PROTECTOR
    K Number
    K811577
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Denver Biomedicals, Inc.
    Date Received
    June 5, 1981
    Decision Date
    August 7, 1981
    Product Code
    HOY
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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    K943968 TUNNELER
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    K842139 THE DENVER PLEURAL-PERITONEAL SHUNT
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