Janzen Lo

FDA Filings

This page includes the latest FDA filings for Janzen Lo. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006395932
FEI Number3006395932
NameJanzen Lo
Owner & OperatorCanwell Medical Co., Ltd.
Contact AddressNo. 466, South Xianhua Street., High-Tech Industrial Zone,
Jinhua CN-33 Zhejiang 321016 CN
Official Correspondent
  • Ming Fang
  • 86-579-82239656-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address137 wyndham dr
Allentown, PA 18104 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3008044507
FEI Number3008044507
NameJanzen Lo
Owner & OperatorCHANGZHOU CONDYN MEDICAL INSTRUMENT CO., LTD
Contact Address9 West LingXiang Road Wujin Economic Development Zone,
Changzhou CN-32 Jiangsu 213149 CN
Official Correspondent
  • XiaoHu Chen
  • 86-519-68020101-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address137 wyndham dr
Allentown, PA 18104 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Janzen Lo [Canwell Medical Co., Ltd.]
INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION2015-07-07
Janzen Lo [Canwell Medical Co., Ltd.]
INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION2015-07-07
Janzen Lo [CHANGZHOU CONDYN MEDICAL INSTRUMENT CO., LTD]
none2009-11-17

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