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

    APEX ALPHA VACUUM PUMP

    K Number: K871570 · Decision Aug 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    118

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    Basic Information

    Device Name
    APEX ALPHA VACUUM PUMP
    K Number
    K871570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Apex Medical, Inc.
    Date Received
    April 22, 1987
    Decision Date
    August 18, 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 Apex Medical, Inc.

    K Number Device Name
    K933965 APEX MEDICAL AIR PUMPS
    K902102 COM-TENS: A NEUROSTIMULATOR
    K882816 PULSAR EM
    K882468 ELIMINATOR AIR FILTER
    K871384 APEX SUCTION CURETTE