Device Classification Name |
mask, surgical
|
510(k) Number |
K211440 |
Device Name |
ASM-301 Level 3 Surgical Mask |
Applicant |
American Surgical Mask Company LLC |
5508 N 50th Street Suite 1000 |
Tampa,
FL
33610
|
|
Applicant Contact |
Matt Brandman |
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 | 05/10/2021 |
Decision Date | 06/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|