E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM


Device Classification Name

esophagoscope (flexible or rigid)

510(k) Number K111030
Device Name E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
Applicant
INTROMEDIC CO., LTD
suite 1104 e&c venture dream
tower 6-cha, 197-28 guro-dong
guro-gu , seoul, 

KR

152719

Applicant Contact jinyoung lee
Regulation Number 874.4710
Classification Product Code
EOX  
Date Received 04/13/2011
Decision Date 10/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No