FDA 510(k) Application Details - K973557

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K973557
Device Name	Lubricant, Patient
Applicant	QUALIS, INC. 4600 PARK AVE. DES MOINES, IA 50321 US Other 510(k) Applications for this Company
Contact	MARY A FINN 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	09/19/1997
Decision Date	10/10/1997
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