Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K082102 |
Device Name |
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 |
Applicant |
APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350 |
AUSTIN,
TX
78746
|
|
Applicant Contact |
DENNIS MCWILLIAMS |
Correspondent |
APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350 |
AUSTIN,
TX
78746
|
|
Correspondent Contact |
DENNIS MCWILLIAMS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/25/2008 |
Decision Date | 06/14/2010 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|