FDA 510(k) Application Details - K111030

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K111030
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	INTROMEDIC CO., LTD SUITE 1104 E&C VENTURE DREAM TOWER 6-CHA, 197-28 GURO-DONG GURO-GU , SEOUL 152719 KR Other 510(k) Applications for this Company
Contact	JINYOUNG LEE Other 510(k) Applications for this Contact
Regulation Number	874.4710   More FDA Info for this Regulation Number
Classification Product Code	EOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2011
Decision Date	10/21/2011
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	Y
Expedited Review