Brenda Mcgivern

FDA Filings

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

FDA Registration(s)
Registration Number3012828634
FEI Number3012828634
NameBrenda McGivern
Owner & OperatorVisionflex Pty Limited
Contact Address1/8 Prosperity Parade Warriewood
Sydney AU-NSW New South Wales 2102 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address532 Page Street
Stoughton, MA 02072 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Brenda McGivern [Visionflex Pty Limited]
Tidishield2017-07-26
Brenda McGivern [Visionflex Pty Limited]
Riester Specula- Otoscope2017-07-26
Brenda McGivern [Visionflex Pty Limited]
Universal FSC2 Camera Handpiece2017-07-26
Brenda McGivern [Visionflex Pty Limited]
LED Light Source - USB2017-07-26
Brenda McGivern [Visionflex Pty Limited]
Intra Oral Camera Lercher2017-07-26
Brenda McGivern [Visionflex Pty Limited]
GEIS - HD General Exam Camera2017-07-26
Brenda McGivern [Visionflex Pty Limited]
FV-HD Base2017-07-26
Brenda McGivern [Visionflex Pty Limited]
FSC3 Multi functional Camera Handpiece2017-07-26
Brenda McGivern [Visionflex Pty Limited]
Endoscope Camera with Adaptor - SD2017-07-26
Brenda McGivern [Visionflex Pty Limited]
Endoscope Camera Head HD Zoom2017-07-26
Brenda McGivern [Visionflex Pty Limited]
RNK PCP-USB Stethoscope2017-07-18
Brenda McGivern [Visionflex Pty Limited]
ProEX2017-06-28
Brenda McGivern [Visionflex Pty Limited]
ProEX Mobile2017-06-28
Brenda McGivern [Visionflex Pty Limited]
Visionflex Pty Limited2016-04-17
Brenda McGivern [Visionflex Pty Limited]
Visionflex Pty Limited2016-04-17

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