Eltech K Laser S R L

FDA Filings

This page includes the latest FDA filings for Eltech K Laser S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004642415
FEI Number3004642415
NameRICHARD KEITH SWANSON
Owner & OperatorELTECH K-LASER, S.R.L.
Contact AddressVIA CASTAGNOLE, 20/H-INTERNO 2 --
TREVISO IT-TV Treviso 31100 IT
US Agent
Importing Logistics Registration
ImporterDJO, LLC
Address1430 Decision Street
Vista, CA 92081 UNITED STATES
Importing Logistics Registration
ImporterSirona Dental System GmbH
AddressFabrikstrasse 31
Bensheim, 64625 GERMANY
SubdivisionDE-HE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address50 TYSON DRIVE
Fair Haven, NJ 07704 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
RICHARD KEITH SWANSON [ELTECH K-LASER, S.R.L.]
K-laser Cube1, K-laser Cube2, K-laser Cube 3, K-laser Cube 42012-09-24
RICHARD KEITH SWANSON [ELTECH K-LASER, S.R.L.]
k-12002009-12-30
RICHARD KEITH SWANSON [ELTECH K-LASER, S.R.L.]
K-Series 12002009-12-30

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