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Sybaritic Agrees With FDA to Suspend US Medical Device Sales

Concerning the article, "FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices", posted on your website, Sybaritic Inc. has released the following response:

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SYBARITIC AGREES WITH FDA TO SUSPEND US MEDICAL DEVICE SALES WHILE IT CONTINUES INTERNATIONAL SALES AND MANUFACTURING

Sybaritic has signed a consent decree with the FDA to suspend selling its medical devices in the US while it works to improve its quality system processes and modify some of its claims. Sybaritic has worked cooperatively with the FDA in the past and has obtained FDA 510(k) clearances to market its medical products. Sybaritic, Inc. does not agree with the allegations in the FDA Complaint, but is cooperating with the FDA to resolve the issues raised.

Sybaritic firmly stands behind the quality of all of its products, and is dedicated to promptly resolving its record-keeping and improving its quality system documentation and processes. The FDA has acknowledged it is not aware of any adverse events concerning Sybaritic's products. FDA attorney Bob Klepinski of Fredrikson & Byron, who represents Sybaritic and its management team, Steven J. Daffer, Anthony S. Daffer and Ronald Berglund, is optimistic that once the FDA conducts a full and fair review of its processes, the FDA's concerns will be satisfied and that Sybaritic soon will be able to resume its U.S. sales of medical devices.

All manufacturing of exports and international sales of Sybaritic's products-including all medical devices, spa capsules, beauty and cosmetic products-will continue unaffected by the consent decree. Sybaritic will also continue its U.S. sales of beauty, cosmetic & non-medical products.

Sybaritic is a recognized worldwide pioneer, distributor and a national leader in beauty and spa products. Sybaritic is the original inventor and world's number one seller of premium quality spa capsules, including the Dermalife, with a world network of suppliers and distributors and a proven safety record.

Any further questions should be directed to Sybaritic's attorneys, Bob Klepinski (rklepinski@fredlaw.com) or Dulce Foster (dfoster@fredlaw.com).