FDA 510(k) Application Details - K992833

Device Classification Name	Stabilizer,Heart   More FDA Info for this Device
510(K) Number	K992833
Device Name	Stabilizer,Heart
Applicant	CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. CUPERTINO, CA 95014-0739 US Other 510(k) Applications for this Company
Contact	Michael Billig Other 510(k) Applications for this Contact
Regulation Number	870.4500   More FDA Info for this Regulation Number
Classification Product Code	MWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/1999
Decision Date	11/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review