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

    DOW CORNING SILASTIC ELASTOMER Q7-4750

    K Number: K973166 · Decision Nov 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    DOW CORNING SILASTIC ELASTOMER Q7-4750
    K Number
    K973166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technical Products, Inc.
    Date Received
    August 25, 1997
    Decision Date
    November 21, 1997
    Product Code
    MIB
    Advisory Committee
    Ear, Nose, Throat
    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
    MIB Elastomer, Silicone Block

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    Other Clearances by Technical Products, Inc.

    K Number Device Name
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    K971613 SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
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