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

    REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER

    K Number: K952407 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    40
    Applicant Total
    18
    Review Days
    77

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    Basic Information

    Device Name
    REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER
    K Number
    K952407
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contour Fabricators of Florida, Inc.
    Date Received
    May 22, 1995
    Decision Date
    August 7, 1995
    Product Code
    KYZ
    Advisory Committee
    General Hospital
    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
    KYZ Syringe, Irrigating (Non Dental)

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