Jiangsu JDC Medical Devices Co., Ltd.

CLOSEOUT LETTER Jiangsu JDC Medical Devices Co., Ltd. MARCS-CMS 598340 — May 20, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Qing (Michael) Yang Jiangsu JDC Medical Devices Co., Ltd. No. 8, Jing 8 Road, Lianyun Development Zone Lianyungang, Jiangsu 222047 China Issuing Office: OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality United States Dear Mr. Yang: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 598340, dated December 16, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely yours, /S/ Courtney H. Lias, Ph.D. Acting Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Fiona Chan SUNGO Technical Service Inc. 6050 W. Eastwood Avenue, Apt. 201 Chicago, Illinois 60630 Content current as of: 05/24/2021 Regulated Product(s) Medical Devices