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

    SYNEVAC VACUUM SOURCE UNIT

    K Number: K831085 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    8
    Review Days
    65

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    Basic Information

    Device Name
    SYNEVAC VACUUM SOURCE UNIT
    K Number
    K831085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Synemed, Inc.
    Date Received
    April 4, 1983
    Decision Date
    June 8, 1983
    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 Synemed, Inc.

    K Number Device Name
    K954037 FIELD TREND
    K852936 THE FIELDMASTER MODEL 275
    K833274 DERMATOLOGY HANDPIECE-OPHTH LASER
    K828585 OPTHALAS PHOTOCOAGULATOR
    K822853 MODEL 200 SQUID
    K813282 SYNEVAC VACUUM CURETTAGE SYSTEMS
    K811270 SCOPE MASTER