FDA 510(k) Application Details - K100716

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K100716
Device Name	Plasma, Coagulation Control
Applicant	AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	DESSI LYAKOV Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2010
Decision Date	06/23/2011
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