FDA 510(k) Application Details - K151491

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K151491
Device Name	Tonometer, Manual
Applicant	FALCK MEDICAL, INC 35 WASHINGTON STREET MYSTIC, CT 06355 US Other 510(k) Applications for this Company
Contact	FRANCIS FALCK Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2015
Decision Date	01/15/2016
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