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

    QUINEVAC II

    K Number: K920629 · Decision Mar 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    406

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    Basic Information

    Device Name
    QUINEVAC II
    K Number
    K920629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Recto Molded Products, Inc.
    Date Received
    February 12, 1992
    Decision Date
    March 24, 1993
    Product Code
    FYD
    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
    FYD Apparatus, Exhaust, Surgical

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    Other Clearances by Recto Molded Products, Inc.

    K Number Device Name
    K920628 QUINEVAC EVACUATOR/ASPIRATOR