BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016

    K Number: K770851 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    42
    Review Days
    66

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    Basic Information

    Device Name
    SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
    K Number
    K770851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Concord Laboratories, Inc.
    Date Received
    May 9, 1977
    Decision Date
    July 14, 1977
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Concord Laboratories, Inc.

    K Number Device Name
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    K862039 CONCORD CARE TRAY
    K854601 SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
    K854327 SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
    K851134 REGIONAL ANESTHESIA TRAYS
    K842095 EPIDURAL TRAYS
    K841486 ARTERIAL BLOOD SAMPLING KITS
    K840986 PREFILLED PULSATOR SYRINGE
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