FDA 510(k) Application Details - K970971

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K970971
Device Name	Stimulator, Nerve
Applicant	UROMED CORP. 64 A ST. NEEDHAM, MA 02194 US Other 510(k) Applications for this Company
Contact	FREDERICK TOBIA Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/1997
Decision Date	10/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review