Device Classification Name |
pediatric/child facemask
|
510(k) Number |
K213427 |
Device Name |
PRIMED Pediatric Facemask |
Applicant |
PRIMED Medical Products Inc. |
200, 2003-91 St, SW, Edmonton, |
Edmonton,
CA
T6X 0W8
|
|
Applicant Contact |
Mitra Fard |
Correspondent |
PRIMED Medical Products Inc. |
200, 2003-91 St, SW, Edmonton, |
Edmonton,
CA
T6X 0W8
|
|
Correspondent Contact |
Mitra Fard |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 10/21/2021 |
Decision Date | 11/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|