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

    DRAIN-R-DRAPE(EYE

    K Number: K831340 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    DRAIN-R-DRAPE(EYE
    K Number
    K831340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sur-Tech, Inc.
    Date Received
    April 25, 1983
    Decision Date
    June 8, 1983
    Product Code
    HMT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HMT Drape, Patient, Ophthalmic

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