FDA 510(k) Application Details - K970328

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K970328
Device Name	Neurosurgical Paddie
Applicant	ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 NORTH STONINGTON, CT 06359 US Other 510(k) Applications for this Company
Contact	GEORGE P KORTEWEG Other 510(k) Applications for this Contact
Regulation Number	882.4700   More FDA Info for this Regulation Number
Classification Product Code	HBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/1997
Decision Date	04/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review