Borla

FDA Filings

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

FDA Registration(s)
Registration Number3011788773
FEI Number3011788773
NameBORLA
Owner & OperatorMondiaLab-USA Corporation
Contact Address5380 Eisenhower Avenue Building C
Alexandria VA 22304 US
Official Correspondent
  • John M Falk
  • 1-202-2159511-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBORLA 3000 Bill Garland Drive
JC, TN 37604 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
BORLA [MondiaLab-USA Corporation]
MONDIALAB PRO kPlex2020-04-01
BORLA [MondiaLab-USA Corporation]
MONDIALAB PRO kPlex2020-04-01

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