BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    SYRIGENE PRE-FILLED SYRINGE

    K Number: K935669 · Decision Feb 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    44
    Applicant Total
    21
    Review Days
    84

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    Basic Information

    Device Name
    SYRIGENE PRE-FILLED SYRINGE
    K Number
    K935669
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Regulatory & Marketing Services, Inc.
    Date Received
    November 26, 1993
    Decision Date
    February 18, 1994
    Product Code
    JDL
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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