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  5. Dexcowin Co. Ltd. - 545388 - 10/25/2023
  1. Warning Letters

CLOSEOUT LETTER

Dexcowin Co. Ltd. MARCS-CMS 545388 —

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

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