Device Classification Name |
Mask, Surgical
|
510(k) Number |
K212451 |
Device Name |
Surgical Mask |
Applicant |
ReMade USA LLC |
2915 E Washington Blvd |
Los Angeles,
CA
90023
|
|
Applicant Contact |
David Durst |
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 | 08/05/2021 |
Decision Date | 09/10/2021 |
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
|
|
|