Customers, by purchasing this equipmentment you certify that you are a licensed practitioner and/or other person regularly and lawfully engaged in the manufacture and/or refurbishing of the medical device items identified herein. You also certify that prior to sale or use of such devices you will take necessary steps to assure that such devices are not adulterated or misbranded within the meaning of those terms in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 311, et seq.)