FDA 510(k) Application Details - K203569

Device Classification Name	More FDA Info for this Device
510(K) Number	K203569
Device Name	Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
Applicant	FCI (France Chirurgie Instrumentation) SAS 20-22 rue Louis Armand Paris 75015 FR Other 510(k) Applications for this Company
Contact	Thierry Fetick Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NCB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2020
Decision Date	06/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review