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

    DENTIST WITH ASSISTANT PACK

    K Number: K940864 · Decision Aug 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    10
    Review Days
    160

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    Basic Information

    Device Name
    DENTIST WITH ASSISTANT PACK
    K Number
    K940864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterile Concepts, Inc.
    Date Received
    February 23, 1994
    Decision Date
    August 2, 1994
    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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    K943047 IV START KITS
    K943090 SUTURE REMOVAL TRAYS
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