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

    CEMENT-PICK

    K Number: K822108 · Decision Aug 11, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    CEMENT-PICK
    K Number
    K822108
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bio-Blitz, Inc.
    Date Received
    July 19, 1982
    Decision Date
    August 11, 1982
    Product Code
    GAF
    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
    GAF Spatula, Surgical, General & Plastic Surgery

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    Other Clearances by Bio-Blitz, Inc.

    K Number Device Name
    K822109 SHOVEL RETRACTOR