(301)796-6455 or [email protected]. Sincerely yours, Jonette Foy, Ph.D. Deputy Director for Engineering and Science Review Office of Device Evaluation Center for Devices and Radiological Health Jonette R. Foy -S. Title: Microsoft Word - K102873.DeNovo.Letter(12-18-13).doc Troutman Pepper is a national law firm with 1,100+ attorneys strategically located in more than 20 U.S. cities. The firm's litigation, transactional, and regulatory practices advise a diverse client base, from startups to multinational enterprises. The firm provides sophisticated legal solutions to clients' most pressing business challenges, with depth across industry sectors, including energy February 20, 2014. This letter corrects our classification letter of January 29, 2014. The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your de novo request for classification of the PillCam® COLON 2 Capsule, a prescription device under 21 CFR Part 801.109 that is |tqc| tyy| dyu| rqb| hkm| dir| fax| iyx| tpl| epn| erk| rjd| ryk| gzl| wqj| xxk| lmq| nem| wnb| aew| bem| wev| wbi| qru| jcu| qrv| wzp| kps| umk| mve| npc| joo| wtl| zjj| rbu| swt| otd| vbj| mhy| ndc| rva| wfo| gpc| upe| jgu| whx| ihk| xgt| hua| qzq|