Judy K Burton

FDA Filings

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

FDA Registration(s)
Registration Number3009086335
FEI Number3009086335
NameJudy K Burton
Owner & OperatorOptimum Medical
Contact AddressTennant Hall Bleinheim Grove
West Yorkshire GB-LDS Leeds LS2 9ET GB
US Agent
Importing Logistics Registration
ImporterAmazon.com.dedc LLC
Address3350 Laurel Ridge Avenue
Ruskin, FL 33570 UNITED STATES
Importer TypeRETAILER
Importing Logistics Registration
ImporterAmazon.com.dedc, Inc.
Address875 Allen Road
Carlisle, PA 17015 UNITED STATES
Importer TypeRETAILER
Importing Logistics Registration
ImporterGolden State FC LLC
Address1555 N. Chrisman Road
Tracy, CA 95304 UNITED STATES
Importer TypeRETAILER
Importing Logistics Registration
ImporterMDW2
Address250 Emerald Drive
Joliet, IL 60433 UNITED STATES
Importer TypeRETAILER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3010 LBJ Frwy 12th Floor
Dallas, TX 75234 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Foreign Private Label Distributor

Registration Number3007769879
FEI Number3007769879
NameJudy K Burton
Owner & OperatorSYSPAL LTD
Contact AddressCOCKSHUTT LANE
BROSELEY GB-SHR Shropshire TF12 5JA GB
Official Correspondent
  • CHRISTOPHER J TRUMAN
  • 044-1952-883188-x
US Agent
Importing Logistics Registration
ImporterADVENA USA
Address3010 LBJ FRWY 12TH FLOOR
Dallas, TX 75234 UNITED STATES
Email Addressjudy.burton@advenausa.com
Phone1 972 2435105
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3010 LBJ Frwy 12th Floor
Dallas, TX 75234 US
Establishment TypeManufacture Medical Device

Registration Number3010693883
FEI Number3010693883
NameJudy K Burton
Owner & OperatorHUREV Co., Ltd.
Contact Address107-3 Dongwhagongdan-ro Munmak-eup Wonju-si
Gangwon-do KR-NOTA 220-801 KR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3010 LBJ Frwy 12th Floor
Dallas, TX 75234 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Judy K Burton [Optimum Medical]
OptiPro N95/FFP2 Particulate Respirator Face Masks2020-04-15
Judy K Burton [Optimum Medical]
OptiPro 3-ply face masks2020-04-15
Judy K Burton [Optimum Medical]
Sheath (Male External Catheters)2019-09-24
Judy K Burton [Optimum Medical]
Ugo Stand with Dignity2018-01-17
Judy K Burton [Optimum Medical]
Ugo Hanger (Drainage Bag Holder)2018-01-17
Judy K Burton [Optimum Medical]
Ugo Fix Sleeve2018-01-17
Judy K Burton [Optimum Medical]
Ugo Fix Catheter Strap2018-01-17
Judy K Burton [Optimum Medical]
Ugo Fix Bag Belt2018-01-17
Judy K Burton [Optimum Medical]
Ugo Drainage Leg Bags2018-01-17
Judy K Burton [Optimum Medical]
Ugo 2L Drainage Bags2018-01-17
Judy K Burton [Optimum Medical]
Multi Fix Gentle2018-01-17
Judy K Burton [Optimum Medical]
Ugo Fix Catheter Strap2018-01-17
Judy K Burton [Optimum Medical]
Ugo Fix Catheter Clip2018-01-17
Judy K Burton [Optimum Medical]
Ugo Catheter Valve2018-01-17
Judy K Burton [HUREV Co., Ltd.]
Cheetah Sensor2014-01-27
Judy K Burton [Optimum Medical]
OptiLube2012-06-19
Judy K Burton [SYSPAL LTD]
HYDRO PHYSIO PRO TRAINER2009-05-12
Judy K Burton [SYSPAL LTD]
HYDRO PHYSIO LIFESTYLE2009-05-12
Judy K Burton [SYSPAL LTD]
HYDRO PHYSIO FUSION2009-05-12
Judy K Burton [SYSPAL LTD]
HYDRO PHYSIO FOCUS2009-05-12

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