Leigh Spotten

FDA Filings

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

FDA Registration(s)
Registration Number3005579585
FEI Number3005579585
NameLeigh Spotten
Owner & OperatorKunststoff Christel GmbH & Co. KG
Contact AddressCarl-Friedrich-Benz-Strasse 6
Bad Durrheim DE-BW Baden-Wurttemberg 78073 DE
Official Correspondent
  • Mario Rosenberger
  • 049-772-69202-193
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2151 E Grand Avenue
El Segundo, CA 90245 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3015131155
FEI Number3015131155
NameLeigh Spotten
Owner & OperatorJosef Frech GmbH & Co. KG
Contact AddressLindenwiesen 5
K?nigsheim DE-BW Baden-Wurttemberg 78598 DE
Official Correspondent
  • Gerhard Frech
  • 49-7429-9400-0
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2151 E Grand Avenue
El Segundo, CA 90245 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Leigh Spotten [Kunststoff Christel GmbH & Co. KG]
Miller2018-11-30
Leigh Spotten [Josef Frech GmbH & Co. KG]
HEADBAND, AUTOCLAV2018-11-29
Leigh Spotten [Josef Frech GmbH & Co. KG]
HEADBAND, SINGLE USE2018-11-29
Leigh Spotten [Josef Frech GmbH & Co. KG]
MOUTH PIECES2018-11-29
Leigh Spotten [Kunststoff Christel GmbH & Co. KG]
CMOS VIDEO OTOSCOPE2018-11-27

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