Device Classification Name |
marker, radiographic, implantable
|
510(k) Number |
K231579 |
Device Name |
MOLLI 2 |
Applicant |
MOLLI Surgical, Inc. |
50 Wellington Street East |
Suite 400 |
Toronto,
CA
M5E 1C8
|
|
Applicant Contact |
Joseph De Croos |
Correspondent |
MOLLI Surgical, Inc. |
50 Wellington Street East |
Suite 400 |
Toronto,
CA
M5E 1C8
|
|
Correspondent Contact |
Joseph De Croos |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 05/31/2023 |
Decision Date | 10/26/2023 |
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
|
|
|