Maria Makela

FDA Filings

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

FDA Registration(s)
Registration Number3016214533
FEI Number3016214533
NameMaria Makela
Owner & OperatorKoite Health Oy
Contact AddressOtakaari 5A
Espoo FI-ES Etela-Suomen laani 02150 FI
Official Correspondent
  • Sakari Nikinmaa
  • 358-40-8222034-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address191 Henry PL
Wyckoff, NJ 07481 US
Establishment TypeManufacture Medical Device



Registration Number3014345367
FEI Number3014345367
NameMaria Makela
Owner & OperatorOcuspecto Oy
Contact AddressKaarinantie 700
Turku FI-LS Lansi-Suomen laani 20540 FI
Official Correspondent
  • Tapio Mantysalo
  • 358-40-5004765-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressWyckoff New Jersey
Wyckoff, NJ 07481 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Maria Makela [Ocuspecto Oy]
Ocusweep? System2018-03-04
Maria Makela [Ocuspecto Oy]
Ocusweep? System2018-03-04

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