Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K953414 |
Device Name |
CPR MICROMASK WITH OXYGEN INLET |
Applicant |
PLASCO, INC. |
4080 MORRISON DR. |
GURNEE,
IL
60031
|
|
Applicant Contact |
GARY S BOTSFORD |
Correspondent |
PLASCO, INC. |
4080 MORRISON DR. |
GURNEE,
IL
60031
|
|
Correspondent Contact |
GARY S BOTSFORD |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 07/20/1995 |
Decision Date | 03/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|