FDA 510(k) Application Details - K131131

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K131131
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	INTROMEDIC CO., LTD 3550 WILSHIRE BLVD #738 LOS ANGELES, CA 90010-2401 US Other 510(k) Applications for this Company
Contact	STEVE KWON 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	04/22/2013
Decision Date	06/21/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review