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Zyno Medical, LLC MARCS-CMS 507058 —

Recipient Name
Chaoyoung Lee, Ph.D.
Recipient Title
President & CEO
Zyno Medical, LLC
Zyno Medical, LLC

177 Pine Street
Natick, MA 01760-1029
United States

Issuing Office:
Center for Devices and Radiological Health

One Montvale Avenue
4th floor
Stoneham, MA 02180
United States

Dear Dr. Lee:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated December 5, 2016. 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

Gina Brackett
Director of Compliance
Office of Medical Device and Radiological Health Division 1
U.S. Food and Drug Administration

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