FDA 510(k) Application Details - K182506

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K182506
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	TearScience, Inc. 5151 McCrimmon Pkwy. Ste. 250 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Christy Coleman Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2018
Decision Date	12/10/2018
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