"The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, We will verify your status as an authorized purchaser of this item before shipping of the item. Contact Information: Simon Medical, Inc 10304 Placer Lane Sacramento, CA 95827 916-380-9733 Direct Number"