FDA 510(k) Application Details - K955887

Device Classification Name	System, Phonocatheter, Intracavitary   More FDA Info for this Device
510(K) Number	K955887
Device Name	System, Phonocatheter, Intracavitary
Applicant	NEWMED CORP. 1575 EYE ST., N.W. WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	DONALD R STONE Other 510(k) Applications for this Contact
Regulation Number	870.1270   More FDA Info for this Regulation Number
Classification Product Code	DXW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/1995
Decision Date	09/05/1996
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