FDA 510(k) Application Details - K131617

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K131617
Device Name	Lubricant, Patient
Applicant	PEDIATRIC PHARMACEUTICALS, INC. 2137 ROUTE 35 HOLMDEL, NJ 07733 US Other 510(k) Applications for this Company
Contact	ROBERT M HARRIS Other 510(k) Applications for this Contact
Regulation Number	880.6375   More FDA Info for this Regulation Number
Classification Product Code	KMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2013
Decision Date	10/03/2013
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