Device Classification Name |
Mask, Surgical
|
510(k) Number |
K202096 |
Device Name |
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On |
Applicant |
EcoGuard Inc. |
700 S Battleground Ave., Suite 103 |
Grover,
NC
28073
|
|
Applicant Contact |
Fang Wang |
Correspondent |
mdi Consultants, Inc. |
55 Northern Blvd, Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Nickita Alexiades |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 07/29/2020 |
Decision Date | 02/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|