KII!1751 Trade / Ethicon Inc. / WW Regulatory Affairs Ethicon Inc. / Summary Submitter Information Company / Interpharm Holdings Inc. / NJ 08876 Brian A. Kanerviko / /
Event
FDA Phase / /
IndustryTerm
subject device / announcements concerning your device / predicate device / manufacturing practice requirements / scientific protocols / bipolar technology / marketed predicate devices / software updates / manufacturing practice / rnedical.device / Internet address / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / CDR4' s office of Surveillance / office of Compliance / office of Device Evaluation / Divisionof Reproductive / Gastro-Renal and Uroldgical Devices Office / Division of Small Manufacturers / International and Consumer Assistance / Newl-Hampshire Avenue Document Mail Center / DEPARtMENT OF HEALTH / Division of Reproductive / Gastro-Renal / and Urologicel Devices / Center for Devices and Radiological Hecalth / Center for Devices / /
DEC -2 20 ,$(t! po~(&3 5 10(k) Premarket Notification GYNECARE VERSAPOINTTM 11 Bipolar Electrosurgery System