FDA 510(k) Application Details - K201892

Device Classification Name	Lacrimal Stents And Intubation Sets   More FDA Info for this Device
510(K) Number	K201892
Device Name	Lacrimal Stents And Intubation Sets
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2020
Decision Date	03/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review