Karen Wolfe Kerker

FDA Filings

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

FDA Registration(s)
Registration Number8043631
FEI Number3009638066
NameKaren Wolfe-Kerker
Owner & OperatorCYCLOMEDICA AUSTRALIA PTY LTD
Contact AddressUnit 4 1 The Crescent
Kingsgrove AU-NSW New South Wales 2208 AU
Official Correspondent
  • Niamh - McAree
  • 61-412-513483-x
US Agent
Importing Logistics Registration
ImporterCyclomedica Australia Pty Ltd
Address75 Business & Technology Park New Illawarra Rd., Lucas Heights
Sydney, 2234 AUSTRALIA
Importer Typemanufaturer
SubdivisionAU-NSW
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1422 Elbridge Payne Rd Suite 200
Chesterfield, MO 63017 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Karen Wolfe-Kerker [CYCLOMEDICA AUSTRALIA PTY LTD]
Technegas Patient Administration Se2007-10-24

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