FDA 510(k) Application Details - K192418

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K192418
Device Name	Unit, Phacofragmentation
Applicant	Raico LLC 26 Plaza Dr Westmont, IL 60559 US Other 510(k) Applications for this Company
Contact	Ravi Nallakrishnan Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2019
Decision Date	05/27/2020
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