FDA 510(k) Application Details - K020586

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K020586
Device Name	Lubricant, Patient
Applicant	BIOFILM, INC. 3121 SCOTT ST. VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	ROBERT L DE ARMOND 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	02/22/2002
Decision Date	01/24/2003
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