FDA 510(k) Application Details - K130043

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K130043
Device Name	Apparatus, Autotransfusion
Applicant	Teleflex Medical, Inc. 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	NATALIE SMITH 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	01/08/2013
Decision Date	02/12/2013
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