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

    LEININGEO AORTIC PUNCH #310-395 & 397

    K Number: K771625 · Decision Sep 12, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    11
    Review Days
    18

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    Basic Information

    Device Name
    LEININGEO AORTIC PUNCH #310-395 & 397
    K Number
    K771625
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    J. Jamner Surgical Instruments, Inc.
    Date Received
    August 25, 1977
    Decision Date
    September 12, 1977
    Product Code
    DWS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWS Instruments, Surgical, Cardiovascular

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    K941565 JARIT RECOMMENDED SINUS INSTRUMENTS
    K932456 JARIT SURGICAL INSTRUMENTS
    K933728 JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339
    K931928 JARIT SURGICAL INSTRUMENTS
    K931959 JARIT SURGICAL INSTRUMENTS
    K931878 JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680
    K771624 COPE LUNG FORCEPS #305-218
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