FDA 510(k) Application Details - K172712

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K172712
Device Name	Lancet, Blood
Applicant	GRI Medical & Electronic Technology Co, Ltd XiuZhou Industry Zone, 1805 Honggao Road JiaXing 314031 CN Other 510(k) Applications for this Company
Contact	Marty D. Paugh Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2017
Decision Date	11/06/2017
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