K 133754 Trade / Name Address Phone Number Integra LifeSciences Corporation / Integra / K962928 Integra LifeSciences Corporation / Senior Regulatory Affairs Specialist Integra Life Sciences Corporation / Product Code(s) GWM Legally / K 121573 Integra LifeSciences Corporation / /
Country
United States / / /
Event
FDA Phase / /
Facility
New Harapshire Avenue Documnent Control Center / / /
IndustryTerm
announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / search existing data sources / /
MedicalTreatment
Catheter / drainage / /
Organization
Division of Postmarket Surveillance / M.S. Director Division of Neurological / Staff PRA / Center for Devices and Radiological Health / Department of Health and Human Services Food / Neurological and Physical Medicine Devices Office / FDA / Administration office of Chief Information officer Paperwork Reduction Act / Public HeaIth Service OF HEALTH / Division of Small Manufacturers / International and Consumer Assistance / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / Drug Administration / New Harapshire Avenue Documnent Control Center / /
Person
Camino Flex Adapter / Camino Flex Ventricular Catheter / Elizabeth McMeniman / Carlos L. Pefla / Joyce M.Whang / Elizabeth MeMeniman / / /
Position
CPA / Affairs Specialist / maximum head / head / /
MAR0[removed]k) SUMMARY A summary of 5 10(k) safety and effectiveness information in accordance with the requirements of 21 CER[removed]a)(1)