FDA 510(k) Application Details - K173944

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K173944
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	Phakos 62 Rue Kleber Montreuil 93100 FR Other 510(k) Applications for this Company
Contact	J. D. Webb Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2017
Decision Date	10/25/2018
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