Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K993528 |
Device Name |
RUSCH EMERGENCY MASK |
Applicant |
RUSCH, INC. |
2450 MEADOWBROOK PKWY. |
DULUTH,
GA
30096
|
|
Applicant Contact |
RONALD YOUNG |
Correspondent |
RUSCH, INC. |
2450 MEADOWBROOK PKWY. |
DULUTH,
GA
30096
|
|
Correspondent Contact |
RONALD YOUNG |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 10/18/1999 |
Decision Date | 05/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|