FDA 510(k) Application Details - K212741

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K212741
Device Name	Implant, Eye Sphere
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	886.3320   More FDA Info for this Regulation Number
Classification Product Code	HPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2021
Decision Date	06/24/2022
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