FDA 510(k) Application Details - K970051

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K970051
Device Name	Device, Biofeedback
Applicant	SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST CARSBAD, CA 92008-6601 US Other 510(k) Applications for this Company
Contact	DAN W MILLER Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/1997
Decision Date	07/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review