Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K950769 |
Device Name |
CPR MICROMASK PLUS CATALOG NO 73-402 |
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 | 02/21/1995 |
Decision Date | 03/10/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|