FDA 510(k) Application Details - K172062

Device Classification Name	More FDA Info for this Device
510(K) Number	K172062
Device Name	AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
Applicant	MedScience Science Research Group, Inc. 16469 Bridlewood Circle Delray Beach, FL 33445 US Other 510(k) Applications for this Company
Contact	Marvin Smollar 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	07/07/2017
Decision Date	03/05/2018
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