FDA 510(k) Application Details - K970107

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K970107
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	UROHEALTH SYSTEMS, INC. 3050 REDHILL AVE. COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	RONALD H BERGESON Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/1997
Decision Date	11/18/1997
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