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

    ACU-LAB

    K Number: K955776 · Decision Jun 5, 1996
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    168

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    Basic Information

    Device Name
    ACU-LAB
    K Number
    K955776
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glederer & Co., Inc.
    Date Received
    December 20, 1995
    Decision Date
    June 5, 1996
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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