Device Classification Name |
prosthesis, esophageal
|
510(k) Number |
K221482 |
Device Name |
Esophageal TTS Stent |
Applicant |
Taewoong Medical Co., Ltd. |
14 Gojeong-Ro, Wolgot-Myeon |
Gimpo-Si,
KR
10022
|
|
Applicant Contact |
Jangsoo Lee |
Correspondent |
Biologics Consulting Group, Inc. |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Matthew Krueger |
Regulation Number | 878.3610
|
Classification Product Code |
|
Date Received | 05/23/2022 |
Decision Date | 06/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|