FDA 510(k) Application Details - K212039

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K212039
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, TX 76134 US Other 510(k) Applications for this Company
Contact	Jwalitha Shankardas 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	06/30/2021
Decision Date	08/23/2021
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