subject device / nitrile rubber / use device / synthetic rubber / natural rubber latex / announcements concerning your device / nitrite rubber / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / healthcare / subject devices / healthcare facilities / Internet address http /
Organization
Division of Postmarket Surveillance / Division of Anesthesiology / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance / DEPARTMENT OF IIEAIT / FDA / General Hospital / Respiratory / Infection Control and Dental Devices Office / Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology / Division of Small Manufacturers / International and Consumer Assistance / /
Person
Tejashri Purchit-Sheth / Wc / Elizabeth F.Claverie / Kwame Ulmer / Jen / / /
Position
Ke-Min Official Correspondent / General Information Establishment Il Manufacturer / Surgeon / powder-free sterile surgeon / /
SHANGHAI MOTEX HEATHCARE CO., LTD. No.369. Jiasong Zhong Road. Huaxin. Qingpu, Shanghai[removed], China Fax: [removed]Telephone: [removed]11. 5 10O(K) Summary of Safety and Effectiveness