FDA 510(k) Application Details - K162365

Device Classification Name	Tourniquet, Pneumatic   More FDA Info for this Device
510(K) Number	K162365
Device Name	Tourniquet, Pneumatic
Applicant	Terumo BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215 US Other 510(k) Applications for this Company
Contact	Nithya Rajan Other 510(k) Applications for this Contact
Regulation Number	878.5910   More FDA Info for this Regulation Number
Classification Product Code	KCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2016
Decision Date	02/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review