FDA 510(k) Application Details - K982419

Device Classification Name	Stabilizer,Heart   More FDA Info for this Device
510(K) Number	K982419
Device Name	Stabilizer,Heart
Applicant	CARDIOTHORACIC SYSTEMS, INC. 10600 NORTH TANTAU AVE. CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	MIKE 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	07/13/1998
Decision Date	01/13/1999
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