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 |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Regulation Number | 874.4710
|
Classification Product Code |
|
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
|
|
|