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

    RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY

    K Number: K955679 · Decision Mar 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    19
    Applicant Total
    18
    Review Days
    89

    Basic Information

    Device Name
    RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
    K Number
    K955679
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Received
    December 14, 1995
    Decision Date
    March 12, 1996
    Product Code
    HIO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

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    Other Clearances by CONTOUR FABRICATORS OF FLORIDA, INC.

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    K955689 RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
    K955684 RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
    K955686 RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
    K955688 RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
    K955678 RNS STERILE DISPOSABLE PUNCTURE TRAY
    K955683 RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    K952396 REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
    Search all 18 clearances from CONTOUR FABRICATORS OF FLORIDA, INC. →