Device Classification Name |
Prosthesis, Esophageal
|
510(k) Number |
K080782 |
Device Name |
NITI-S ESOPHAGEAL STENT |
Applicant |
TAEWOONG MEDICAL CO., LTD |
5536 TROWBRIDGE DRIVE |
DUNWOODY,
GA
30338
|
|
Applicant Contact |
CATHRYN N CAMBRIA |
Correspondent |
TAEWOONG MEDICAL CO., LTD |
5536 TROWBRIDGE DRIVE |
DUNWOODY,
GA
30338
|
|
Correspondent Contact |
CATHRYN N CAMBRIA |
Regulation Number | 878.3610
|
Classification Product Code |
|
Date Received | 03/19/2008 |
Decision Date | 01/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|