Device Classification Name |
mask, surgical
|
510(k) Number |
K202214 |
Device Name |
IFM Surgical Mask Model SM3 |
Applicant |
FSSC, LLC |
3300 West Clark St. |
rensselaer,
IN
47978
|
|
Applicant Contact |
clayton geyer |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
prithul bom |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/06/2020 |
Decision Date | 03/02/2021 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|