Renee Gaeta

FDA Filings

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

FDA Registration(s)
Registration Number3012883202
FEI Number3012883202
NameRenee Gaeta
Owner & OperatorEstablishment Labs S.A.
Contact AddressCoyol Free Zone & Business Park Building 4th Street, Building B-15
Alajuela CR-A Alajuela 10138-1000 CR
Official Correspondent
  • Natalia Soto
  • 506-243-42400-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address712 Fifth Avenue, 14th Floor
New York, NY 10019 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Renee Gaeta [Establishment Labs S.A.]
Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix?2019-10-29

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