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

    PSI SKULL CLAMP

    K Number: K002276 · Decision Aug 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    PSI SKULL CLAMP
    K Number
    K002276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    V. Mueller Neuro/Spine
    Date Received
    July 26, 2000
    Decision Date
    August 29, 2000
    Product Code
    HBL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by V. Mueller Neuro/Spine

    K Number Device Name
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    K972750 TAKA ANEURYSM CLIP
    K964402 VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
    K942601 PSI FLEXIBLE ARM
    K943635 ULTRA-LINE RONGEUR