Wayne Matelski

FDA Filings

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

Wayne Matelski holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3002987375
FEI Number3002987375
NameWayne Matelski
Owner & OperatorSOFIC SAS
Contact Address3, rue Jean-Jacques Rousseau Aussillon
Mazamet Cedex FR-NOTA 81207 FR
Official Correspondent
  • CHRISTOPHE - COMBES
  • 33-05-63977165-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment TypeManufacture Medical Device



Registration Number3004443427
FEI Number3004443427
NameWayne Matelski
Owner & OperatorSEPTODONT
Contact Address58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES
CEDEX FR-NOTA 94107 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment TypeManufacture Medical Device



Registration Number9610964
FEI Number1000477999
NameWayne Matelski
Owner & OperatorSEPTODONT
Contact Address58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES
CEDEX FR-NOTA 94107 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9613744
FEI Number3002771638
NameWayne Matelski
Owner & OperatorDuoject Medical Systems
Contact Address50 chemin de Gaspe, Complex B5
Bromont CA-QC Quebec J2L2N8 CA
Official Correspondent
  • Maud Richard
  • 001-450-5343666-24
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3002807757
FEI Number3002807757
NameWayne Matelski
Owner & OperatorNovocol Pharmaceutical of Canada, Inc.
Contact Address25 Wolseley Court
Cambridge CA-ON Ontario N1R 6X3 CA
Official Correspondent
  • Leslie Fillion
  • 1-519-6234800-6354
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment TypeForeign Private Label Distributor



FDA Filings

Device
Company
DeviceDate
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Biodentine2015-04-29
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Biodentine2015-04-29
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
XL Septoject2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Septoject Disposable2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Safety Plus XL2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Safco2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Quala2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Patterson2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Henry Schein2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Evolution2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Darby2015-04-28
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Benco2015-04-28
Wayne Matelski [Duoject Medical Systems]
E-Z-Link2014-12-08
Wayne Matelski [Novocol Pharmaceutical of Canada, Inc.]
Ultra Safety Handle2014-11-25
Wayne Matelski [Duoject Medical Systems]
INTER-VIAL2007-11-21

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