FDA 510(k) Application Details - K113689

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K113689
Device Name	Lubricant, Patient
Applicant	DUKAL CORPORATION 2 FLEETWOOD CT RONKONKOMA, NY 11779 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB 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	12/15/2011
Decision Date	05/04/2012
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