Suzhou Gemmed Medical Instrument Co L T D

FDA Filings

This page includes the latest FDA filings for Suzhou Gemmed Medical Instrument Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011327501
• FEI Number: 3011327501
• Name: Jim MacNee
• Owner & Operator: Suzhou Gemmed Medical Instrument Co., Ltd.
• Contact Address: A22 &26, Science &Technology Development Jinnan Rd., Jinfeng Town; Zhangjiagang CN-32 Jiangsu 215625 CN
• Official Correspondent:
  • Baron Lu
  • 86-512-5895653-x
• US Agent:
  • Jim MacNee
  • USDeviceAgent.com
  • 951 8486626
  • Jmacnee@USDeviceAgent.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 85 Plaza De Las Flores , San Juan Capis ; San Juan Capistrano, CA 92675 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K151592 | MNI Jim MacNee [Suzhou Gemmed Medical Instrument Co., Ltd.]	JMR	2016-12-29
PMN K151592 | MNH Jim MacNee [Suzhou Gemmed Medical Instrument Co., Ltd.]	JMR	2016-12-29
PMN K151592 SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD.	Gemmed Pedicle Screw Spinal System	2015-09-24