FDA 510(k) Application Details - K012178

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K012178
Device Name	Apparatus, Autotransfusion
Applicant	FRESENIUS HEMOTECHNOLOGY, INC. 6675 185TH AVE. NE, SUITE 100 REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	TOM TROTTER 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	07/12/2001
Decision Date	07/23/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review