Sofregen Medical Inc

FDA Filings

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

FDA Registration(s)
Registration Number3013417188
FEI Number3013417188
NameSOFREGEN MEDICAL INC.
Owner & OperatorSofregen Medical Inc.
Contact Address200 Boston Ave Suite 1100
Medford MA 02155 US
Official Correspondent
  • William J Gorman
  • x-978-3170836-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 BOSTON AVE STE 1100
Medford, MA 02155 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SOFREGEN MEDICAL INC.
SilkVoice SV30012021-07-29
SOFREGEN MEDICAL INC.
SilkVoice SV30012021-07-29
SOFREGEN MEDICAL INC.
SilkVoice SV20012021-07-29
SOFREGEN MEDICAL INC.
SilkVoice SV10022021-07-29
SOFREGEN MEDICAL INC.
SilkVoice SV10022021-07-29
SOFREGEN MEDICAL INC.
SilkVoice SV20012020-08-17
SOFREGEN MEDICAL INC.
SilkVoice SV10012020-08-17
SOFREGEN MEDICAL INC.
SilkVoice SV10012020-03-09
SOFREGEN MEDICAL INC.
SilkVoice2020-01-13
Sofregen Medical, Inc.
Silk Voice2018-11-08
SOFREGEN MEDICAL INC.
SERI Contour 955122018-07-06
SOFREGEN MEDICAL INC.
SERI 2018-07-06
SOFREGEN MEDICAL INC.
SERI 2018-07-06
SOFREGEN MEDICAL INC.
SERI 2018-07-06
SOFREGEN MEDICAL INC.
SERI 2018-07-06
SOFREGEN MEDICAL INC.
Seri Contour2018-01-18
Sofregen Medical, Inc.
SERI Contour2017-09-22
SOFREGEN MEDICAL INC.
SERI Surgical Scaffold2016-11-15

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