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

    SCALP VEIN SET

    K Number: K771271 · Decision Sep 12, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    SCALP VEIN SET
    K Number
    K771271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Berman, Pcp & Consultants, Inc.
    Date Received
    June 20, 1977
    Decision Date
    September 12, 1977
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Berman, Pcp & Consultants, Inc.

    K Number Device Name
    K771983 SCALP VEIN SET
    K771269 BLOOD COLLECTION SET TYPE H
    K771270 BLOOD ADMINISTRATION TYPE R
    K771267 INFUSION SET TYPE S
    K771272 DISP. SYRINGES: 2,5 & L0 MI.
    K771268 INFUSION SET TYPE J