Maureen Oconnell

FDA Filings

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

FDA Registration(s)

• Registration Number: 9680671
• FEI Number: 3003465293
• Name: Maureen OConnell
• Owner & Operator: QUANTEL MEDICAL
• Contact Address: 11 Rue de Bois Joli CS 40015; Cournon d?Auvergne, Cedex FR-NOTA 63808 FR
• Official Correspondent:
  • Bruno - Pages
  • 33-47-3745732-x
• US Agent:
  • Maureen OConnell
  • OConnell Regulatory Consultants, Inc.
  • 978 2071245
  • maureen@oconnellregulatory.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 44 Oak Street ; Stoneham, MA 02180 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3011787398
• FEI Number: 3011787398
• Name: Maureen OConnell
• Owner & Operator: Beneli AB
• Contact Address: Porfyrgatan 5 ; Helsingborg SE-M Skane lan [SE-12] 25468 SE
• Official Correspondent:
  • Jenny Elvstrand
  • 46-42-256016-x
• US Agent:
  • Maureen OConnell
  • OConnell Regulatory Consultants, Inc.
  • 978 2071245
  • maureen@oconnellregulatory.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 44 Oak Street ; Stoneham, MA 02180 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3002912166
• FEI Number: 3002912166
• Name: Maureen OConnell
• Owner & Operator: Camurus AB
• Contact Address: Ideon Science Park ; Lund SE-M Skane lan [SE-12] SE-223 70 SE
• Official Correspondent:
  • Johan Billstrom
  • 046-46-2865748-x
• US Agent:
  • Maureen OConnell
  • O'Connell Regulatory Consultants, Inc.
  • 978 2071245
  • maureen@oconnellregulatory.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 44 Oak Street ; Stoneham, MA 02180 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3002806978
• FEI Number: 3002806978
• Name: Maureen OConnell
• Owner & Operator: Rechon Life Science AB
• Contact Address: Soldattorpsvagen 5 ; Limhamn SE-M Skane lan [SE-12] 21613 SE
• Official Correspondent:
  • Marie Rexelius
  • 046-40-361168-x
• US Agent:
  • Maureen OConnell
  • OConnell Regulatory Consultants, Inc.
  • 978 2071245
  • maureen@oconnellregulatory.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 44 Oak Street ; Stoneham, MA 02180 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K191962 | GEX Maureen OConnell [QUANTEL MEDICAL]	Vitra 2	2019-12-08
PMN K183414 | IYO Maureen OConnell [QUANTEL MEDICAL]	ABSOLU	2019-03-26
KYT Maureen OConnell [QUANTEL MEDICAL]	LacryDiag	2018-04-06
PMN K180265 | IYO Maureen OConnell [QUANTEL MEDICAL]	COMPACT TOUCH Ophthalmic Ultrasound System	2018-03-05
PMN K170067 | HQF Maureen OConnell [QUANTEL MEDICAL]	Easyret	2017-07-31
DRX Maureen OConnell [Beneli AB]	Universal Patch	2015-06-08
DRX Maureen OConnell [Beneli AB]	Snap Strip	2015-06-08
DRX Maureen OConnell [Beneli AB]	Patch	2015-06-08
DRX Maureen OConnell [Beneli AB]	Patch electrode	2015-06-08
DRX Maureen OConnell [Beneli AB]	MCOT patch	2015-06-08
DRX Maureen OConnell [Beneli AB]	Fast Fix ECG Electrode	2015-06-08
DRX Maureen OConnell [Beneli AB]	BodyGuardian Mini Strip	2015-06-08
PMN K140336 | HQF Maureen OConnell [QUANTEL MEDICAL]	OPTIMIS Fusion YAG/SLT	2014-07-22
PMN K100678 | GEX Maureen OConnell [QUANTEL MEDICAL]	Suprascan Delivery System	2012-06-20
PMN K101769 | MGQ Maureen OConnell [Rechon Life Science AB]	episil	2011-12-29
PMN K101769 | MGQ Maureen OConnell [Camurus AB]	episil	2011-12-14
PMN K094038 | IYO Maureen OConnell [QUANTEL MEDICAL]	AXIS NANO	2010-04-28
PMN K094038 | ITX Maureen OConnell [QUANTEL MEDICAL]	AXIS NANO	2010-04-28
PMN K091581 | HQF Maureen OConnell [QUANTEL MEDICAL]	Supra 577.Y	2009-09-03
PMN P050026 | MVF Maureen OConnell [QUANTEL MEDICAL]	ACTIVIS	2006-09-07
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	VITRA	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	VITRA MULTISPOT	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	VIRIDIS TWIN	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	SUPRA	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	SUPRA T810	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	OPTIMIS-II,VIRIDIS	1996-09-12
PMN K043613 | HQF Maureen OConnell [QUANTEL MEDICAL]	IRIDIS	1996-09-12
PMN K051851 | IYO Maureen OConnell [QUANTEL MEDICAL]	COMPACT Touch	1995-09-15
PMN K051851 | IYO Maureen OConnell [QUANTEL MEDICAL]	COMPACT TOUCH STS/UBM	1995-09-15
PMN K051851 | IYO Maureen OConnell [QUANTEL MEDICAL]	CINESCAN FAMILY	1995-09-15
PMN K051851 | IYO Maureen OConnell [QUANTEL MEDICAL]	AXIS Touch	1995-09-15
PMN K051851 | IYO Maureen OConnell [QUANTEL MEDICAL]	AVISO	1995-09-15
PMN K051851 | ITX Maureen OConnell [QUANTEL MEDICAL]	COMPACT Touch	1995-09-15
PMN K051851 | ITX Maureen OConnell [QUANTEL MEDICAL]	COMPACT TOUCH STS/UBM	1995-09-15
PMN K051851 | ITX Maureen OConnell [QUANTEL MEDICAL]	CINESCAN FAMILY	1995-09-15
PMN K051851 | ITX Maureen OConnell [QUANTEL MEDICAL]	AXIS Touch	1995-09-15
PMN K051851 | ITX Maureen OConnell [QUANTEL MEDICAL]	AVISO	1995-09-15

Similar & Related FDA Registered Companies

• OConnell Regulatory Consultants, Inc.
• O'Connell Regulatory Consultants, Inc.