FDA 510(k) Application Details - K083189

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K083189
Device Name	Lubricant, Patient
Applicant	AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE. SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	PATRICIA A GOEREE 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	10/29/2008
Decision Date	11/21/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review