FDA 510(k) Application Details - K160197

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K160197
Device Name	Apparatus, Autotransfusion
Applicant	Haemonetics Corporation 400 WOOD ROAD BRAINTREE, MA 02184 US Other 510(k) Applications for this Company
Contact	Mark Anzalone Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2016
Decision Date	05/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review