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

    SOLCOVAC WOUND DRAINAGE SYSTEM

    K Number: K915867 · Decision Aug 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    10
    Review Days
    227

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    Basic Information

    Device Name
    SOLCOVAC WOUND DRAINAGE SYSTEM
    K Number
    K915867
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Solco Basle, Inc.
    Date Received
    December 31, 1991
    Decision Date
    August 14, 1992
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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    Other Clearances by Solco Basle, Inc.

    K Number Device Name
    K913247 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K913177 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K896857 SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
    K896858 SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
    K896203 SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
    K883058 SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
    K872590 SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
    K872157 HALL VEIN STRIPPER
    K843821 SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS