FDA 510(k) Application Details - K042449

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K042449
Device Name	Syringe, Balloon Inflation
Applicant	SEDAT S.A. 45900 PARSIPPANY COURT TEMECULA, CA 92592 US Other 510(k) Applications for this Company
Contact	LAETITIA BERNARD Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	MAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2004
Decision Date	04/18/2005
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