FDA 510(k) Application Details - K983122

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K983122
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	MILL-ROSE LABORATORY 7310 CORPORATE BLVD. MENTOR, OH 44060-4885 US Other 510(k) Applications for this Company
Contact	ALAN C POJE 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	09/08/1998
Decision Date	10/30/1998
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