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

    THE ELEVENTH FINGER

    K Number: K923835 · Decision Jul 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    343

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    Basic Information

    Device Name
    THE ELEVENTH FINGER
    K Number
    K923835
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guardian Angel Products, Inc.
    Date Received
    July 31, 1992
    Decision Date
    July 9, 1993
    Product Code
    GDF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDF Guide, Needle, Surgical

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    Other Clearances by Guardian Angel Products, Inc.

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    K923840 NEEDLE-GRABBER
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    K896985 ZAP-GUARD