FDA 510(k) Application Details - K151562

Device Classification Name	Detectors And Removers, Lice, (Including Combs)   More FDA Info for this Device
510(K) Number	K151562
Device Name	Detectors And Removers, Lice, (Including Combs)
Applicant	Piedmont Pharmaceuticals, LLC 204 Muirs Chapel Road, Ste 200 Greensboro, NC 27410 US Other 510(k) Applications for this Company
Contact	Kathleen G. Palma 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	06/10/2015
Decision Date	05/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review