Device Classification Name |
Staple, Implantable
|
510(k) Number |
K173443 |
FOIA Releasable 510(k) |
K173443
|
Device Name |
AEON Endoscopic Stapler |
Applicant |
Lexington Medical Inc. |
11 Executive Park Drive |
Billerica,
MA
01862
|
|
Applicant Contact |
Donna Gasper |
Correspondent |
Lexington Medical Inc. |
11 Executive Park Drive |
Billerica,
MA
01862
|
|
Correspondent Contact |
Donna Gasper |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 11/06/2017 |
Decision Date | 02/01/2018 |
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
|
|
|