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

    SHOVEL RETRACTOR

    K Number: K822109 · Decision Jul 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    298
    Registration Numbers
    298
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    SHOVEL RETRACTOR
    K Number
    K822109
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Bio-Blitz, Inc.
    Date Received
    July 19, 1982
    Decision Date
    July 30, 1982
    Product Code
    NBH
    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
    NBH Accessories, Arthroscopic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NBH), ordered by most recent decision date.

    IRRIGATION SET

    FDA 510(k)
    FDA Class 1 ·Orthopedic
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    Other Clearances by Bio-Blitz, Inc.

    K Number Device Name
    K822108 CEMENT-PICK