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

    NEEDLE & BLADE COUNTER

    K Number: K820332 · Decision Feb 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    NEEDLE & BLADE COUNTER
    K Number
    K820332
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Abco Dist.
    Date Received
    February 8, 1982
    Decision Date
    February 23, 1982
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

    Similar 510(k) Clearances

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    SURGICAL INSTRUMENT TRAY

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    ARTHROSCOPY TRAY

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    HEART CATH TRAY

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    Other Clearances by Abco Dist.

    K Number Device Name
    K820510 TYMPANOSTOMY TUBES (VARIOUS MODELS