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

    IV ADMINISTRATION SET

    K Number: K871908 · Decision Jul 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    206
    Review Days
    73

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    Basic Information

    Device Name
    IV ADMINISTRATION SET
    K Number
    K871908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    May 15, 1987
    Decision Date
    July 27, 1987
    Product Code
    BRZ
    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
    BRZ Set, Blood Transfusion

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    Other Clearances by Travenol Laboratories, S.A.

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    K873984 AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
    K865029 CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
    K870169 CAPILLARY FLOW DIALYZERS
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