FDA 510(k) Application Details - K961137

Device Classification Name	Pump, Blood, Extra-Luminal   More FDA Info for this Device
510(K) Number	K961137
Device Name	Pump, Blood, Extra-Luminal
Applicant	APHERESIS TECHNOLOGIES, INC. 612 FLORIDA AVE. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	JOHN B CORNISH Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/1996
Decision Date	06/14/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review