FDA 510(k) Application Details - K162917

Device Classification Name	More FDA Info for this Device
510(K) Number	K162917
Device Name	Allerhope Allergy Skin Tester
Applicant	PROCARE INDUSTRIAL CO., LIMITED NO.5-2-9-160, SCIENCE AVENUE 89 HI-TECH ZONE ZHENGZHOU 450000 CN Other 510(k) Applications for this Company
Contact	WANG YANHONG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2016
Decision Date	08/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review