FDA 510(k) Application Details - K082755

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K082755
Device Name	Syringe, Balloon Inflation
Applicant	SEDAT 8895 TOWNE CENTRE DRIVE 105-416 SAN DIEGO, CA 92122 US Other 510(k) Applications for this Company
Contact	CHARLES COUSIN 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	09/19/2008
Decision Date	12/15/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review