Device Classification Name |
clip, implantable
|
510(k) Number |
K220006 |
Device Name |
angioLOCK Polymer Ligating Clip |
Applicant |
A2 Medical Systems, LLC |
6387 Technology Ave. |
Kalamazoo,
MI
49009
|
|
Applicant Contact |
Robert Hall |
Correspondent |
A2 Medical Systems, LLC |
6387 Technology Ave. |
Kalamazoo,
MI
49009
|
|
Correspondent Contact |
Robert Hall |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2022 |
Decision Date | 03/02/2022 |
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
|
|
|