Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K083418 |
Device Name |
CPR MASK |
Applicant |
FIRSTAR HEALTHCARE CO., LTD. |
3500 SOUTH DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Applicant Contact |
YOVETTE MUMFORD |
Correspondent |
FIRSTAR HEALTHCARE CO., LTD. |
3500 SOUTH DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Correspondent Contact |
YOVETTE MUMFORD |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 11/18/2008 |
Decision Date | 07/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|