FDA 510(k) Application Details - K032827

Device Classification Name	Container, Empty, For Collection & Processing Of Blood & Blood Components   More FDA Info for this Device
510(K) Number	K032827
Device Name	Container, Empty, For Collection & Processing Of Blood & Blood Components
Applicant	TYCO HEALTHCARE 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	GAIL CHRISTIE Other 510(k) Applications for this Contact
Regulation Number	864.9100   More FDA Info for this Regulation Number
Classification Product Code	KSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2003
Decision Date	12/08/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review