Sagemax Bioceramics, Inc.

CLOSEOUT LETTER Sagemax Bioceramics, Inc. MARCS-CMS 439941 — February 15, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Medical Devices Recipient: Recipient Name Sheng Dang Recipient Title President and Owner Sagemax Bioceramics, Inc. 34210 9th Avenue South Ste. 118 Federal Way , WA 98003 United States Issuing Office: Division of Medical Device and Radiological Health Operations West United States Dear Mr. Dang: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (SEA #15-06), dated 12/09/2014. 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, /S/ Kelly D. Sheppard Compliance Branch Director Division 3/West Office of Medical Device and Radiological Health Operations Content current as of: 01/15/2020 Regulated Product(s) Medical Devices