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

    STACKHOUSE LENS HOOD, MODEL SA-700/F

    K Number: K000605 · Decision Aug 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    4
    Review Days
    176

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    Basic Information

    Device Name
    STACKHOUSE LENS HOOD, MODEL SA-700/F
    K Number
    K000605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stackhouse, Inc.
    Date Received
    February 23, 2000
    Decision Date
    August 17, 2000
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Stackhouse, Inc.

    K Number Device Name
    K003194 STACKHOUSE LENS HOOD, MODEL SA-700/FS
    K001082 STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
    K944116 FREEDOM ASPIRATOR, MODEL 6000