FDA 510(k) Application Details - K080042

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K080042
Device Name	Lubricant, Patient
Applicant	SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE AYER, MA 01432 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU 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	01/08/2008
Decision Date	04/03/2008
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