Dexcowin Co. Ltd.

CLOSEOUT LETTER Dexcowin Co. Ltd. MARCS-CMS 545388 — October 25, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Raymond Ryu Recipient Title CEO Dexcowin Co. Ltd. 901~905 25 Gasan Digital 1-Ro Geumcheon-gu Seoul 08594 South Korea sbryu@dexcowin.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Ryu: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letters (CMS Case No. 545388, dated February 20, 2018, and CMS Case No. 474468, dated August 11, 2015). Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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, /S/ Robert Ochs, Ph.D. Director OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Joyce St. Germain U.S. Agent The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, Florida 32174 Joyce510kfda@gmail.com Content current as of: 11/07/2023 Regulated Product(s) Medical Devices