FDA 510(k) Application Details - K161521

Device Classification Name	More FDA Info for this Device
510(K) Number	K161521
Device Name	TAP Blood Collection Device
Applicant	Seventh Sense Biosystems, Inc. 200 BOSTON AVE SUITE 3700 MEDFORD, MA 02155 US Other 510(k) Applications for this Company
Contact	TIM RICHARDS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2016
Decision Date	02/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review