Device Classification Name |
Mask, Surgical
More FDA Info for this Device |
510(K) Number |
K220670 |
Device Name |
Mask, Surgical |
Applicant |
Magnum Health And Safety Pvt Ltd
Unit No. 21, 22, 23, Supreme Industrial Estate, Lucky
Compound, Near Bhajanlal Dairy,Chinchoti Naka,Village Devdal
Taluka - Vasai, Dist - Palghar 401208 IN
Other 510(k) Applications for this Company
|
Contact |
Rakesh Bhagat
Other 510(k) Applications for this Contact |
Regulation Number |
878.4040
More FDA Info for this Regulation Number |
Classification Product Code |
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/07/2022 |
Decision Date |
06/28/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|