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

    ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR

    K Number: K971100 · Decision May 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
    K Number
    K971100
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atrion Medical Products, Inc.
    Date Received
    March 26, 1997
    Decision Date
    May 23, 1997
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EIA Unit, Operative Dental

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