Bolder Surgical

FDA Filings

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

FDA Registration(s)
Registration Number3010377594
FEI Number3010377594
NameBOLDER SURGICAL, LLC
Owner & OperatorBolder Surgical
Contact Address331 South 104th Street Suite 200
Louisville CO 80027 US
Official Correspondent
  • Claire C Bronstein
  • 1-720-2877146-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address331 S. 104th Street Suite 200
LOUISVILLE, CO 80027 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight Surgical Vessel Sealing System2016-09-28
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight Sealer2016-09-28
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight Generator2016-09-28
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Stapler2016-09-28
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Reload2016-09-28
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Stapler2014-06-23
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Reload2014-06-23
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Stapler2014-06-23
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight 5mm Reload2014-06-23
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight Sealer2013-06-27
BOLDER SURGICAL, LLC [Bolder Surgical]
JustRight Generator2013-06-27

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