FDA 510(k) Application Details - K971753

Device Classification Name	Apparatus, Suction, Patient Care   More FDA Info for this Device
510(K) Number	K971753
Device Name	Apparatus, Suction, Patient Care
Applicant	DENVER BIOMATERIALS, INC. 14998 W. 6TH AVE. BLDG. E700 GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	LYNNE LEONARD Other 510(k) Applications for this Contact
Regulation Number	870.5050   More FDA Info for this Regulation Number
Classification Product Code	DWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/1997
Decision Date	06/27/1997
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review