FDA 510(k) Application Details - K964522

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K964522
Device Name	Device, Cystometric, Hydraulic
Applicant	ANDROMEDA MEDIZINISCHE SYSTEME GMBH 9109 COPENHAVER DR. POTOMAC, MD 20854 US Other 510(k) Applications for this Company
Contact	NORMAN F ESTRIN, PH.D. , RAC Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	FEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1996
Decision Date	03/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review