FDA 510(k) Application Details - K970018

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K970018
Device Name	Instrument, Ent Manual Surgical
Applicant	L.W. WARD AND ASSOC., INC. 4655 KIRKWOOD COURT BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LEWIS W WARD Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1997
Decision Date	03/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review