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

    THE EXTRACTOR I TM

    K Number: K801327 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    277
    Registration Numbers
    277
    Same Product Code
    4
    Applicant Total
    60
    Review Days
    6

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    Basic Information

    Device Name
    THE EXTRACTOR I TM
    K Number
    K801327
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    The Anspach Effort, Inc.
    Date Received
    June 3, 1980
    Decision Date
    June 9, 1980
    Product Code
    HWB
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HWB Extractor

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