FDA 510(k) Application Details - K143177

Device Classification Name	Dispenser, Liquid Medication   More FDA Info for this Device
510(K) Number	K143177
Device Name	Dispenser, Liquid Medication
Applicant	KleenGel, LLC 136 NW 16th Street Boca Raton, FL 33432 US Other 510(k) Applications for this Company
Contact	Suzanne Mair Other 510(k) Applications for this Contact
Regulation Number	880.6430   More FDA Info for this Regulation Number
Classification Product Code	KYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2014
Decision Date	09/14/2015
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