FDA 510(k) Application Details - K003830

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K003830
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. SCHAUMBURG, IL 60193-4426 US Other 510(k) Applications for this Company
Contact	NICK MIRCEA Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2000
Decision Date	04/09/2001
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