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

    RULE, PUPILLARY

    K Number: K873440 · Decision Sep 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    25

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    Basic Information

    Device Name
    RULE, PUPILLARY
    K Number
    K873440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1190
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Allegheny Plastics, Inc.
    Date Received
    August 27, 1987
    Decision Date
    September 21, 1987
    Product Code
    HMM
    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
    HMM Distometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HMM), ordered by most recent decision date.

    DISTOMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
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