Device Classification Name |
mask, surgical
|
510(k) Number |
K211275 |
Device Name |
AirMax Procedure Mask |
Applicant |
PremiumEStore, LLC |
2601 Reliance Drive, Suite 102 |
Virginia Beach,
VA
23452
|
|
Applicant Contact |
Brent Dillie |
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 | 04/27/2021 |
Decision Date | 05/25/2021 |
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
|
|
|