FDA 510(k) Application Details - K060643

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K060643
Device Name	Syringe, Balloon Inflation
Applicant	ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. ARAB, AL 35016 US Other 510(k) Applications for this Company
Contact	DAN CLARK 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	03/10/2006
Decision Date	07/12/2006
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