Device Classification Name |
Staple, Implantable
|
510(k) Number |
K182380 |
Device Name |
AEON Endoscopic Stapler |
Applicant |
Lexington Medical, Inc. |
11 Executive Park Drive |
Billerica,
MA
01862
|
|
Applicant Contact |
Douglas MacBride |
Correspondent |
Lexington Medical, Inc. |
11 Executive Park Drive |
Billerica,
MA
01862
|
|
Correspondent Contact |
Douglas MacBride |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 08/31/2018 |
Decision Date | 11/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|