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

    STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT

    K Number: K952678 · Decision Jul 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    10
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
    K Number
    K952678
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avail-Southwest Division
    Date Received
    June 12, 1995
    Decision Date
    July 10, 1995
    Product Code
    KDG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDG Chisel (Osteotome)

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    K Number Device Name
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    K933520 ENDOSCOPIC ANTI-FOG KIT, 100-302-00
    K864158 THERMAPAD