BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    PENNINE LINK YANKAUERS

    K Number: K844874 · Decision Jun 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    378
    Registration Numbers
    378
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    171

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    Basic Information

    Device Name
    PENNINE LINK YANKAUERS
    K Number
    K844874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pennine Medical , Ltd.
    Date Received
    December 17, 1984
    Decision Date
    June 6, 1985
    Product Code
    GEA
    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
    GEA Cannula, Surgical, General & Plastic Surgery

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    Other Clearances by Pennine Medical , Ltd.

    K Number Device Name
    K854443 O'NEIL URINARY CATHETER INTRODUCER
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    K852081 PENNINE OXYGEN LINK TUBING
    K844876 PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
    K852079 PENNINE DERBY YANKAUER
    K852080 PENNINE SUCTION CATHETERS
    K844873 PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4