FDA 510(k) Application Details - K953681

Device Classification Name	Separator, Automated, Blood Cell And Plasma, Therapeutic   More FDA Info for this Device
510(K) Number	K953681
Device Name	Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant	HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 BRAINTREE, MA 02184 US Other 510(k) Applications for this Company
Contact	ALICIA R LOPEZ Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/1995
Decision Date	06/04/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review