Ken Li

FDA Filings

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

FDA Registration(s)
Registration Number3005060582
FEI Number3005060582
NameKen Li
Owner & OperatorZIBO SINOCARE PLASTIC PRODUCTS CO., LTD.
Contact AddressLot 5, No. 21 Qingtian Road, Qilu Chemical Industrial Park
Zibo CN-37 Shandong 255414 CN
Official Correspondent
  • CHEN - YAN
  • 86-533-7488136-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment TypeManufacture Medical Device



Registration Number3006946173
FEI Number3006946173
NameKen Li
Owner & OperatorPinnacle Co., Ltd
Contact AddressLot 2, No. 21 Qingtian Road Qilu Chemical Industrial Park
Linzi, Zibo CN-37 Shandong 255414 CN
Official Correspondent
  • David Ding
  • 86-533-7489957-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment TypeManufacture Medical Device



Registration Number3007707004
FEI Number3007707004
NameKen Li
Owner & OperatorShandong Huayue Glove Co., Ltd.
Contact AddressEast of Yifan Rd. and North of Naqi Rd. Science and Technology Based Ind. Zone
Zibo CN-37 Shandong 255400 CN
Official Correspondent
  • Jinyou Lin
  • 86-533-6217666-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



Registration Number3015335977
FEI Number3015335977
NameKen Li
Owner & OperatorHe Chuang Plastic & Rubber Co., Ltd
Contact Address6-27, Qilu International Plastic Park,Li
Zibo CN-37 Shandong 255400 CN
Official Correspondent
  • Coco Wang
  • 86-533-7859085-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment TypeManufacture Medical Device



Registration Number3009243435
FEI Number3009243435
NameKen Li
Owner & OperatorBlue Sail Medical Co., Ltd
Contact AddressNo. 21 Qingtian Road, Qilu Chemcial Industrial Park,
Zibo CN-37 Shandong 255414 CN
Official Correspondent
  • Robin Liu
  • 86-533-7854785-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment TypeManufacture Medical Device



Registration Number3009512322
FEI Number3009512322
NameKen Li
Owner & OperatorINPRO TECHNOLOGY DEVICE FACTORY
Contact AddressNo.10-1, Xing'an Road East, Linqu
WEIFANG CN-37 Shandong 262600 CN
Official Correspondent
  • Yanmei Wang
  • 86-536-2197065-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Constitution Drive, Suite 1D
Bedford, NH 03110 US
Establishment TypeManufacture Medical Device



FDA Owner/Operator Registration



FDA Filings

Device
Company
DeviceDate
Ken Li [Shandong Huayue Glove Co., Ltd.]
Huayue2019-07-11
Ken Li [INPRO TECHNOLOGY DEVICE FACTORY]
omnishield2016-06-23
Ken Li [INPRO TECHNOLOGY DEVICE FACTORY]
Inpro2016-06-23
Ken Li [Blue Sail Medical Co., Ltd]
Blue Sail or Multiple2008-11-11
Ken Li [Blue Sail Medical Co., Ltd]
Blue Sail or Multiple2008-11-11
Ken Li [Pinnacle Co., Ltd]
omnishield2008-02-15
Ken Li [Pinnacle Co., Ltd]
Omnishied2008-02-15
Ken Li [Pinnacle Co., Ltd]
omnishield2008-02-15

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