GI DYNAMICS, INC. (OTCMKTS:GIDYL) Files An 8-K Other Events

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GI DYNAMICS, INC. (OTCMKTS:GIDYL) Files An 8-K Other Events
Item 8.01 Other Events.

On November10, 2017 (November 11, 2017 Australian Eastern Daylight Time), GI Dynamics, Inc. (the “Company”) received notification (the “CE Mark Notice”) from its notified body, SGS United Kingdom, Limited (“SGS”), that SGS will withdraw the CE Certificate of Conformity for EndoBarrier effective November12, 2017. Withdrawal of the CE Certificate of Conformity means that the Company will not be able to affix the CE Mark and sell EndoBarrier in European Union countries until another Certificate of Conformity is issued by SGS or another notified body or any appeal is successful. On November13, 2017, the Company issued a press release announcing the receipt of the CE Mark Notice. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 8.01 Financial Statements and Exhibits.

(d) Exhibits


GI DYNAMICS, INC. Exhibit
EX-99.1 2 d494386dex991.htm EX-99.1 EX-99.1 Exhibit 99.1     Boston,…
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