FDA 510(k) Application Details - K953676

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K953676
Device Name	Syringe, Balloon Inflation
Applicant	NAMIC PRUYNS ISLAND GLENS FALLS, NY 12801 US Other 510(k) Applications for this Company
Contact	MARY MEAGHER RUBIN 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	08/07/1995
Decision Date	03/29/1996
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