Dune Medical Devices Inc

FDA Filings

This page includes the latest FDA filings for Dune Medical Devices Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Dune Medical Devices Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Danette Wilson

FDA Registration(s)

Registration Number	3010060126
FEI Number	3010060126
Name	DUNE MEDICAL DEVICES INC
Owner & Operator	Dune Medical Devices, Inc.
Contact Address	6120 Windward Parkway Suite 160 Alpharetta GA 30005 US
Official Correspondent	Robin Fatzinger 1-610-9843569-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	6120 Windward Parkway, Suite 160 Alpharetta, GA 30005 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P110014S010 DUNE MEDICAL DEVICES INC	MarginProbe System	2019-12-02
PMA P110014S009 DUNE MEDICAL DEVICES INC	MarginProbe System	2019-09-20
PMA P110014S008 DUNE MEDICAL DEVICES INC	MarginProbe System	2019-06-19
PMA P110014S007 DUNE MEDICAL DEVICES INC	DUNE MEDICAL DEVICES MARGINPROBE SYSTEM	2016-03-30
PMA P110014S006 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2016-03-14
PMA P110014S005 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2015-05-18
PMA P110014S004 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2014-10-22
PMA P110014S003 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2014-09-24
PMA P110014S002 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2014-05-15
PMA P110014S001 DUNE MEDICAL DEVICES INC	MARGINPROBE SYSTEM	2014-04-29
PMN P110014 \| OEE DUNE MEDICAL DEVICES INC [Dune Medical Devices, Inc.]	MarginProbe System	2013-01-17
PMN P110014 \| OEE DUNE MEDICAL DEVICES INC [Dune Medical Devices, Inc.]	MarginProbe Probe	2013-01-17
PMN P110014 \| OEE DUNE MEDICAL DEVICES INC [Dune Medical Devices, Inc.]	MarginProbe Console	2013-01-17
PMA P110014 DUNE MEDICAL DEVICES INC	DUNE MEDICAL DEVICES MARGINPROBE SYSTEM	2012-12-27

Related Finance Registrations

NCAGE Code	7F8F1	DUNE MEDICAL DEVICES, INC.
CAGE Code	7F8F1	DUNE MEDICAL DEVICES, INC.
S.A.M. Registration	7F8F1 [16974745]	DUNE MEDICAL DEVICES, INC.
DUNS	016974745	Dune Medical Devices, Inc.