FDA 510(k) Application Details - K061103

Device Classification Name	Microfilter, Blood Transfusion   More FDA Info for this Device
510(K) Number	K061103
Device Name	Microfilter, Blood Transfusion
Applicant	HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 BRAINTREE, MA 02184 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	CAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2006
Decision Date	05/17/2006
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	Y
Expedited Review