FDA 510(k) Application Details - K142715

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K142715
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	Sensor Medical Technology, LLC 23175 224th Place SE Maple Valley, WA 98038 US Other 510(k) Applications for this Company
Contact	Louise Culham 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	09/22/2014
Decision Date	12/16/2014
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