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

    VAN DELLEN ASPIRATOR

    K Number: K873462 · Decision Sep 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    VAN DELLEN ASPIRATOR
    K Number
    K873462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Van Dellen, Ltd.
    Date Received
    August 28, 1987
    Decision Date
    September 25, 1987
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Van Dellen, Ltd.

    K Number Device Name
    K873465 VAN DELLEN BACTERIA FILTER
    K873463 VAN DELLEN ASPIRATING TUBING
    K873464 VAN DELLEN CANNULA
    K873162 VAN DELLEN RETROBULBAR NEEDLE
    K873163 VAN DELLEN IRRIGATING CYSTOTOME
    K873164 VAN DELLEN HEALON CANNULA