FDA 510(k) Application Details - K172375

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K172375
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 US Other 510(k) Applications for this Company
Contact	Kate Ueda 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	08/07/2017
Decision Date	09/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review