FDA 510(k) Application Details - K163401

Device Classification Name	Detectors And Removers, Lice, (Including Combs)   More FDA Info for this Device
510(K) Number	K163401
Device Name	Detectors And Removers, Lice, (Including Combs)
Applicant	MEDTECH PRODUCTS INC. 660 WHITE PLAINS ROAD TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	JEAN BOYKO Other 510(k) Applications for this Contact
Regulation Number	880.5960   More FDA Info for this Regulation Number
Classification Product Code	LJL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2016
Decision Date	03/21/2017
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