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

    S-SCORT (2500)

    K Number: K964997 · Decision Mar 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    S-SCORT (2500)
    K Number
    K964997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sscor
    Date Received
    December 16, 1996
    Decision Date
    March 5, 1997
    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 Sscor

    K Number Device Name
    K041154 S-SCORT...JR QUICKDRAW, MODEL 2400
    K952632 S-SCORT
    K950464 SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES
    K945929 S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP