FDA 510(k) Application Details - K231106

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K231106
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	Medicel AG Dornierstrasse 11 Altenrhein 9423 CH Other 510(k) Applications for this Company
Contact	Erik Braziulis Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	MSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2023
Decision Date	09/19/2023
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