FDA 510(k) Application Details - K120702

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K120702
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	JIN YOUNG 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	03/08/2012
Decision Date	06/20/2012
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